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Clinical Trial Results:
A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease

Summary
EudraCT number	2016-001634-10
Trial protocol	SE FI ES BE DK NL IT
Global end of trial date	28 Jul 2021

Results information
Results version number	v1
This version publication date	21 Jul 2022
First version publication date	21 Jul 2022
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M15-566

ISRCTN number

US NCT number

NCT02880956

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road,, Maidenhead, Berkshire, United Kingdom, SL6 4UB

Public contact

Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com

Scientific contact

Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG , 001 8006339110, abbvieclinicaltrials@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

28 Jul 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 Jul 2021

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study are: ● To assess the efficacy of ABBV-8E12 in slowing disease progression (cognitive and functional impairment) in subjects with Early AD as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). ● To assess the long-term safety of ABBV-8E12 for up to 96 weeks in subjects with Early AD.

Protection of trial subjects

Subject and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Jan 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 31

Country: Number of subjects enrolled

Belgium: 16

Country: Number of subjects enrolled

Canada: 26

Country: Number of subjects enrolled

Denmark: 7

Country: Number of subjects enrolled

Finland: 12

Country: Number of subjects enrolled

Italy: 34

Country: Number of subjects enrolled

Netherlands: 7

Country: Number of subjects enrolled

New Zealand: 12

Country: Number of subjects enrolled

Spain: 28

Country: Number of subjects enrolled

Sweden: 12

Country: Number of subjects enrolled

United States: 268

Worldwide total number of subjects

453

EEA total number of subjects

116

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

360

85 years and over

Subject disposition

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Recruitment details

Screening details

Participants underwent screening procedures within 12 weeks prior to initial study drug administration. Participants who signed informed consent and did not randomize because they did not complete the study-specific procedures during the Screening Period or did not meet all entry criteria were considered Screen Failures.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Arm type

Placebo

Investigational medicinal product name

placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Placebo was given by IV infusion, preferably in the morning. Participant weight was obtained prior to study drug administration to determine the appropriate infusion rate.

ABBV-8E12 300 mg

Arm description

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Arm type

Experimental

Investigational medicinal product name

ABBV-8E12

Investigational medicinal product code

Other name

tilavonemab

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

ABBV-8E12 was given by IV infusion, preferably in the morning. Participant weight was obtained prior to study drug administration to determine the appropriate infusion rate.

ABBV-8E12 1000 mg

Arm description

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Arm type

Experimental

Investigational medicinal product name

ABBV-8E12

Investigational medicinal product code

Other name

tilavonemab

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

ABBV-8E12 was given by IV infusion, preferably in the morning. Participant weight was obtained prior to study drug administration to determine the appropriate infusion rate.

ABBV-8E12 2000 mg

Arm description

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Arm type

Experimental

Investigational medicinal product name

ABBV-8E12

Investigational medicinal product code

Other name

tilavonemab

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

ABBV-8E12 was given by IV infusion, preferably in the morning. Participant weight was obtained prior to study drug administration to determine the appropriate infusion rate.

Number of subjects in period 1	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Started	116	108	116	113
Completed	99	93	105	95
Not completed	17	15	11	18
Consent withdrawn by subject	9	4	6	11
Other, not specified	4	2	-	3
Adverse event	3	6	5	4
COVID-19 logistical restrictions	1	2	-	-
Lost to follow-up	-	1	-	-

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 300 mg

Reporting group description

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 1000 mg

Reporting group description

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 2000 mg

Reporting group description

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Reporting group values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg	Total
Number of subjects	116	108	116	113	453
Age categorical
Units: Subjects
< 65 years	15	24	17	29	85
>= 65 years	101	84	99	84	368
Gender categorical
Units: Subjects
Female	70	45	60	59	234
Male	46	63	56	54	219
Race
Units: Subjects
Asian	2	3	0	0	5
Native Hawaiian or Other Pacific Islander	0	0	1	0	1
Black or African American	2	3	1	1	7
White	111	102	113	111	437
More than one race	1	0	1	1	3
Ethnicity
Units: Subjects
Hispanic or Latino	4	6	4	3	17
None	112	102	112	110	436
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.
Units: score on a scale
arithmetic mean (standard deviation)	3.0 ( 1.22 )	3.0 ( 1.12 )	3.1 ( 1.24 )	2.9 ( 1.14 )	-

End points

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Reporting group title

Placebo

Reporting group description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 300 mg

Reporting group description

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 1000 mg

Reporting group description

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 2000 mg

Reporting group description

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Primary: Change From Baseline Over Time in CDR-SB Score

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End point title

Change From Baseline Over Time in CDR-SB Score ^[1]

End point description

The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=participants with an assessment at given time point.

End point type

Primary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analyses for this endpoint are in the attached document; the EudraCT system could not accommodate the data correctly.

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=110, 108, 116, 113	0.60 ( 0.125 )	0.66 ( 0.129 )	0.44 ( 0.125 )	0.63 ( 0.130 )
Change to Week 48; n=105, 97, 105, 98	1.06 ( 0.155 )	1.15 ( 0.161 )	1.05 ( 0.154 )	0.99 ( 0.161 )
Change to Week 72; n=100, 93, 101, 95	1.90 ( 0.213 )	1.88 ( 0.220 )	1.85 ( 0.212 )	1.81 ( 0.219 )
Change to Week 96; n=85, 85, 91, 81	2.54 ( 0.271 )	2.47 ( 0.277 )	2.48 ( 0.267 )	2.70 ( 0.279 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) ^[2]

End point description

A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug. Safety Dataset: participants who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented per protocol.

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: participants
Any TEAE	108	94	108	104
Severe TEAE	12	13	14	11
TEAE With a Reasonable Possibility to Study Drug	28	32	31	33
SAE	26	19	22	17
TEAE Leading to Discontinuation of Study Drug	4	6	6	4
Fatal TEAE	1	2	2	1
All Deaths	1	2	2	1

No statistical analyses for this end point

Secondary: Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[3]

End point description

Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. n=Participants with an evaluable sample at given time point.

End point type

Secondary

End point timeframe

Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: μg/mL
geometric mean (geometric coefficient of variation)
First Dosing Interval; n=12, 17, 9	108 ( 28 )	284 ( 21 )	528 ( 27 )
Fourth Dosing Interval; n=11, 17, 8	168 ( 23 )	426 ( 20 )	806 ( 37 )

No statistical analyses for this end point

Secondary: Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[4]

End point description

End point type

Secondary

End point timeframe

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: hours
median (full range (min-max))
First Dosing Interval; n=12, 17, 9	3 (1.8 to 4.2)	2.5 (1.3 to 4.2)	2.7 (1.7 to 3.6)
Fourth Dosing Interval; n=11, 17, 8	2.4 (1.1 to 4.1)	2.5 (1.7 to 4.3)	2.3 (1.7 to 3.6)

No statistical analyses for this end point

Secondary: Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[5]

End point description

End point type

Secondary

End point timeframe

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: μg/mL
geometric mean (geometric coefficient of variation)
First Dosing Interval; n=12, 17, 9	28.6 ( 22 )	75.1 ( 33 )	163 ( 26 )
Fourth Dosing Interval; n=11, 17, 8	56.4 ( 25 )	182 ( 29 )	320 ( 36 )

No statistical analyses for this end point

Secondary: Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[6]

End point description

Harmonic mean is presented in the data table. Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. n=Participants with an evaluable sample at given time point.

End point type

Secondary

End point timeframe

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: days
arithmetic mean (standard deviation)
First Dosing Interval; n=12, 17, 9	22.0 ( 17.2 )	19.4 ( 8.87 )	33.2 ( 10.5 )
Fourth Dosing Interval; n=11, 17, 8	19.6 ( 6.09 )	24.0 ( 16.6 )	37.5 ( 13.5 )

No statistical analyses for this end point

Secondary: Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[7]

End point description

End point type

Secondary

End point timeframe

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: μg.day/mL
geometric mean (geometric coefficient of variation)
First Dosing Interval; n=12, 17, 9	2520 ( 28 )	6090 ( 37 )	14800 ( 25 )
Fourth Dosing Interval; n=11, 17, 8	4230 ( 33 )	13100 ( 36 )	30200 ( 36 )

No statistical analyses for this end point

Secondary: Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[8]

End point description

End point type

Secondary

End point timeframe

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: μg/mL/mg
geometric mean (geometric coefficient of variation)
First Dosing Interval; n=12, 17, 9	0.359 ( 28 )	0.284 ( 21 )	0.264 ( 27 )
Fourth Dosing Interval; n=11, 17, 8	0.561 ( 23 )	0.426 ( 20 )	0.403 ( 37 )

No statistical analyses for this end point

Secondary: AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

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End point title

AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses ^[9]

End point description

End point type

Secondary

End point timeframe

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: PK analysis was only done for participants receiving active study drug.

End point values	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	12	17	9
Units: μg.day/mL/mg
geometric mean (geometric coefficient of variation)
First Dosing Interval; n=12, 17, 9	8.40 ( 28 )	6.09 ( 37 )	7.41 ( 25 )
Fourth Dosing Interval; n=11, 17, 8	14.1 ( 33 )	13.1 ( 36 )	15.1 ( 36 )

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADASCog- 14) Total Score

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End point title

Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADASCog- 14) Total Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=104, 103, 110, 99	1.82 ( 0.492 )	1.42 ( 0.498 )	0.56 ( 0.480 )	1.86 ( 0.503 )
Change at Week 48; n=98, 89, 102, 87	4.50 ( 0.621 )	3.51 ( 0.642 )	3.42 ( 0.605 )	4.03 ( 0.647 )
Change at Week 72; n=91, 88, 92, 85	5.26 ( 0.718 )	4.78 ( 0.730 )	5.00 ( 0.706 )	6.37 ( 0.738 )
Change at Week 96; n=72, 78, 77, 64	8.43 ( 0.898 )	7.99 ( 0.891 )	7.84 ( 0.872 )	9.46 ( 0.935 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n= Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.01 ( 0.038 )	0.03 ( 0.038 )	0.04 ( 0.037 )	0.08 ( 0.039 )
Change at Week 48; n=102, 92, 105, 93	0.03 ( 0.044 )	0.09 ( 0.046 )	0.07 ( 0.044 )	0.12 ( 0.046 )
Change at Week 72; n=100, 92, 96, 95	0.17 ( 0.064 )	0.11 ( 0.066 )	0.14 ( 0.064 )	0.31 ( 0.066 )
Change at Week 96; n=81, 81, 87, 76	0.30 ( 0.083 )	0.26 ( 0.083 )	0.19 ( 0.080 )	0.29 ( 0.085 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.11 ( 0.057 )	0.05 ( 0.058 )	-0.02 ( 0.056 )	0.09 ( 0.059 )
Change at Week 48; n=102, 92, 105, 93	0.07 ( 0.073 )	0.23 ( 0.077 )	0.17 ( 0.072 )	0.20 ( 0.077 )
Change at Week 72; n=100, 92, 96, 94	0.25 ( 0.069 )	0.22 ( 0.072 )	0.16 ( 0.070 )	0.16 ( 0.071 )
Change at Week 96; n=80, 81, 86, 75	0.41 ( 0.089 )	0.25 ( 0.089 )	0.026 ( 0.086 )	0.33 ( 0.092 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Commands Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Commands Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.09 ( 0.066 )	0.10 ( 0.067 )	0.09 ( 0.065 )	0.09 ( 0.068 )
Change at Week 48; n=102, 92, 105, 93	0.17 ( 00.72 )	0.12 ( 0.076 )	0.09 ( 0.071 )	0.22 ( 0.075 )
Change at Week 72; n=100, 92, 96, 95	0.09 ( 0.078 )	0.11 ( 0.081 )	0.36 ( 0.079 )	0.21 ( 0.080 )
Change at Week 96; n=81, 81, 86, 76	0.30 ( 0.102 )	0.36 ( 0.103 )	0.40 ( 0.100 )	0.40 ( 0.106 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	115	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=109, 106, 113, 102	0.11 ( 0.133 )	0.17 ( 0.135 )	-0.04 ( 0.131 )	-0.09 ( 0.137 )
Change at Week 48; n=101, 92, 105, 93	0.41 ( 0.133 )	0.30 ( 0.138 )	0.32 ( 0.131 )	0.27 ( 0.138 )
Change at Week 72; n=99, 92, 96, 95	0.39 ( 0.132 )	0.61 ( 0.136 )	0.52 ( 0.133 )	0.67 ( 0.135 )
Change at Week 96; n=79, 81, 86, 76	0.86 ( 0.135 )	0.80 ( 0.135 )	0.60 ( 0.131 )	0.66 ( 0.138 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 112, 102	0.05 ( 0.057 )	0.13 ( 0.058 )	0.02 ( 0.056 )	0.18 ( 0.059 )
Change at Week 48; n=102, 92, 105, 93	0.21 ( 0.075 )	0.12 ( 0.078 )	0.09 ( 0.073 )	0.16 ( 0.078 )
Change at Week 72; n=99, 92, 96, 94	0.18 ( 0.083 )	0.25 ( 0.086 )	0.21 ( 0.083 )	0.35 ( 0.085 )
Change at Week 96; 80, 81, 86, 75	0.35 ( 0.111 )	0.26 ( 0.112 )	0.41 ( 0.108 )	0.42 ( 0.114 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	114	107	116	112
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=107, 104, 111, 101	0.15 ( 0.130 )	-0.04 ( 0.132 )	-0.20 ( 0.129 )	0.17 ( 0.134 )
Change at Week 48; n=100, 89, 104, 88	0.37 ( 0.147 )	0.07 ( 0.154 )	0.21 ( 0.145 )	0.28 ( 0.155 )
Change at Week 72; n=97, 89, 93, 88	0.32 ( 0.160 )	0.14 ( 0.166 )	0.04 ( 0.162 )	0.40 ( 0.167 )
Change at Week 96; n=74, 80, 80, 70	0.52 ( 0.184 )	0.29 ( 0.181 )	0.60 ( 0.179 )	0.52 ( 0.190 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	113	108	115	112
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=107, 106, 112, 100	0.33 ( 0.099 )	0.33 ( 0.100 )	0.35 ( 0.097 )	0.32 ( 0.102 )
Change at Week 48; n=99, 92, 103, 92	0.43 ( 0.114 )	0.42 ( 0.118 )	0.42 ( 0.112 )	0.22 ( 0.118 )
Change at Week 72; n=95, 92, 93, 91	0.75 ( 0.115 )	0.68 ( 0.117 )	0.44 ( 0.115 )	0.68 ( 0.118 )
Change at Week 96; n=76, 80, 83, 70	0.87 ( 0.138 )	0.84 ( 0.137 )	0.74 ( 0.133 )	0.77 ( 0.143 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Naming Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	114	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=108, 106, 113, 102	0.02 ( 0.048 )	0.08 ( 0.049 )	-0.03 ( 0.047 )	0.05 ( 0.050 )
Change at Week 48; n=101, 92, 105, 93	0.11 ( 0.049 )	0.09 ( 0.051 )	0.08 ( 0.048 )	0.03 ( 0.050 )
Change at Week 72; n=97, 92, 96, 95	0.21 ( 0.063 )	0.14 ( 0.065 )	0.08 ( 0.063 )	0.07 ( 0.064 )
Change at Week 96; n=79,80, 86, 75	0.34 ( 0.085 )	0.34 ( 0.086 )	0.28 ( 0.082 )	0.20 ( 0.087 )

Attachments

Untitled (Filename: ADAS-Cog-14 Naming Score_SA.docx)

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.08 ( 0.127 )	0.42 ( 0.130 )	0.08 ( 0.125 )	0.49 ( 0.132 )
Change at Week 48; n=102, 92, 105, 93	0.63 ( 0.147 )	0.77 ( 0.154 )	0.45 ( 0.145 )	0.61 ( 0.153 )
Change at Week 72; n=100, 92, 96, 95	1.01 ( 0.166 )	0.84 ( 0.172 )	1.02 ( 0.167 )	1.05 ( 0.171 )
Change at Week 96; n=80, 81, 86, 76	1.26 ( 0.196 )	1.46 ( 0.197 )	1.28 ( 0.191 )	2.00 ( 0.202 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.16 ( 0.098 )	0.03 ( 0.100 )	0.16 ( 0.097 )	0.11 ( 0.101 )
Change at Week 48; n=102, 92, 105, 93	0.39 ( 0.101 )	0.32 ( 0.105 )	0.41 ( 0.100 )	0.38 ( 0.105 )
Change at Week 72; n=100, 92, 96, 94	0.58 ( 0.113 )	0.64 ( 0.117 )	0.60 ( 0.114 )	0.70 ( 0.116 )
Change at Week 96; n=81, 81, 88, 76	1.04 ( 0.131 )	0.97 ( 0.132 )	0.89 ( 0.127 )	0.91 ( 0.135 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.03 ( 0.050 )	0.03 ( 0.051 )	0.15 ( 0.049 )	-0.02 ( 0.052 )
Change at Week 48; n=102, 92, 105, 93	0.27 ( 0.071 )	0.10 ( 0.074 )	0.19 ( 0.070 )	0.06 ( 0.074 )
Change at Week 72; n=100, 92, 96, 95	0.24 ( 0.091 )	0.19 ( 0.094 )	0.29 ( 0.091 )	0.26 ( 0.093 )
Change at Week 96; n=80, 81, 82, 72	0.40 ( 0.112 )	0.45 ( 0.113 )	0.27 ( 0.111 )	0.46 ( 0.117 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

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End point title

Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADASCog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.07 ( 0.045 )	0.08 ( 0.046 )	0.06 ( 0.045 )	0.11 ( 0.047 )
Change at Week 48; n=102, 92, 105, 93	0.14 ( 0.051 )	0.04 ( 0.054 )	0.03 ( 0.051 )	0.11 ( 0.053 )
Change at Week 72; n=100, 92, 96, 95	0.23 ( 0.066 )	0.11 ( 0.069 )	0.19 ( 0.066 )	0.24 ( 0.068 )
Change at Week 96; n=81, 81, 87, 76	0.29 ( 0.089 )	0.23 ( 0.090 )	0.25 ( 0.087 )	0.43 ( 0.092 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.21 ( 0.071 )	0.14 ( 0.073 )	0.11 ( 0.070 )	0.23 ( 0.074 )
Change at Week 48; n=102, 92, 105, 93	0.25 ( 0.077 )	0.19 ( 0.081 )	0.21 ( 0.077 )	0.31 ( 0.081 )
Change at Week 72; n=100, 92, 96, 95	0.47 ( 0.093 )	0.28 ( 0.096 )	0.44 ( 0.094 )	0.42 ( 0.096 )
Change at Week 96; n= 81, 81, 87, 76	0.58 ( 0.117 )	0.35 ( 0.119 )	0.47 ( 0.114 )	0.60 ( 0.121 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Top of page

End point title

Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

End point description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=110, 106, 113, 102	0.53 ( 0.248 )	0.25 ( 0.253 )	-0.20 ( 0.245 )	-0.02 ( 0.257 )
Change at Week 48; n=102, 92, 105, 93	1.35 ( 0.257 )	0.92 ( 0.270 )	0.73 ( 0.254 )	0.80 ( 0.268 )
Change at Week 72; n=100, 92, 96, 95	0.65 ( 0.245 )	1.05 ( 0.255 )	0.78 ( 0.249 )	0.88 ( 0.252 )
Change at Week 96; n=80, 81, 82, 72	1.98 ( 0.287 )	1.97 ( 0.287 )	1.53 ( 0.283 )	2.09 ( 0.301 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Top of page

End point title

Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

End point description

FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). FAQ score ranges from 0-30 and consists of 10 items (each scored from 0-3), which measure a specific iADL in the past 4 weeks: [1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; 10) traveling out of the neighborhood]. Performance in each category is rated from 0-3: 0=normal; 1=has difficulty, but does by self; 2=requires assistance; or 3=dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance. Intent-to-Treat Data Set. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=112, 105, 111, 103	1.63 ( 0.422 )	1.84 ( 0.435 )	1.19 ( 0.423 )	2.06 ( 0.439 )
Change at Week 48; n=105, 96, 106, 98	3.37 ( 0.480 )	3.53 ( 0.498 )	2.83 ( 0.477 )	3.58 ( 0.496 )
Change at Week 72; n=100, 95, 101, 96	5.62 ( 0.571 )	5.09 ( 0.588 )	4.57 ( 0.568 )	6.31 ( 0.586 )
Change at Week 96; n=86, 85, 92, 82	6.14 ( 0.650 )	7.11 ( 0.663 )	5.80 ( 0.638 )	7.94 ( 0.667 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

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End point title

Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

End point description

The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 48; n=99, 95, 104, 95	4.91 ( 0.078 )	4.86 ( 0.080 )	4.80 ( 0.076 )	4.87 ( 0.079 )
Change at Week 96; n=83, 83, 89, 80	5.29 ( 0.087 )	5.28 ( 0.087 )	5.22 ( 0.083 )	5.34 ( 0.088 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Top of page

End point title

Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

End point description

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 48; n=99, 95, 104, 95	4.85 ( 0.080 )	4.81 ( 0.081 )	4.83 ( 0.077 )	4.92 ( 0.081 )
Change at Week 96; n=83, 83, 89, 80	5.30 ( 0.092 )	5.29 ( 0.092 )	5.22 ( 0.088 )	5.34 ( 0.093 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

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End point title

Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

End point description

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 48; n=99, 95, 104, 95	4.30 ( 0.061 )	4.31 ( 0.062 )	4.28 ( 0.059 )	4.33 ( 0.062 )
Change at Week 96; n=83, 83, 89, 80	4.61 ( 0.079 )	4.49 ( 0.078 )	4.57 ( 0.076 )	4.55 ( 0.080 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

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End point title

Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

End point description

The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 48; n=99, 95, 104, 95	4.59 ( 0.071 )	4.58 ( 0.072 )	4.46 ( 0.068 )	4.59 ( 0.072 )
Change at Week 96; n=83, 83, 89, 80	4.97 ( 0.088 )	4.95 ( 0.088 )	4.98 ( 0.085 )	5.03 ( 0.090 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

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End point title

Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

End point description

The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	114	112
Units: score on a scale
least squares mean (standard error)
Change to Week 48; n=98, 93, 102, 88	-4.47 ( 1.533 )	-6.04 ( 1.567 )	-4.10 ( 1.500 )	-8.96 ( 1.601 )
Change to Week 96; n=77, 79, 81, 73	-13.36 ( 2.047 )	-12.74 ( 2.037 )	-11.55 ( 1.994 )	-14.85 ( 2.104 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

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End point title

Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

End point description

The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 48, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	114	108	114	113
Units: score on a scale
least squares mean (standard error)
Change to Week 48; n=103, 98, 105, 98	-3.72 ( 0.723 )	-4.51 ( 0.738 )	-2.91 ( 0.712 )	-3.65 ( 0.740 )
Change to Week 98; n=83, 85, 87, 79	-9.21 ( 1.134 )	-10.25 ( 1.135 )	-9.16 ( 1.112 )	-10.60 ( 1.163 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

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End point title

Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	115	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=108, 105, 107, 100	-3.52 ( 0.640 )	-4.83 ( 0.649 )	-5.04 ( 0.637 )	-5.17 ( 0.664 )
Change to Week 48; n=98, 90, 101, 88	-1.85 ( 0.757 )	-1.37 ( 0.782 )	-1.86 ( 0.746 )	-2.67 ( 0.792 )
Change to Week 72; n=94, 87, 90, 86	-5.27 ( 0.861 )	-5.95 ( 0.885 )	-6.86 ( 0.862 )	-6.38 ( 0.897 )
Change to Week 96; n=74, 75, 79, 64	-6.79 ( 0.923 )	-7.78 ( 0.928 )	-6.59 ( 0.901 )	-7.03 ( 0.977 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Coding Total Score

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End point title

Change From Baseline Over Time in RBANS - Coding Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=109, 105, 110, 100	-0.39 ( 0.600 )	-1.29 ( 0.611 )	-1.40 ( 0.595 )	-1.40 ( 0.623 )
Change to Week 48; n=98, 90, 103, 90	-1.98 ( 0.673 )	-1.17 ( 0.694 )	-2.38 ( 0.660 )	-3.14 ( 0.698 )
Change to Week 72; n=95, 89, 91, 88	-5.26 ( 0.799 )	-2.80 ( 0.819 )	-4.58 ( 0.799 )	-4.53 ( 0.828 )
Change to Week 96; n=77, 76, 80, 65	-6.12 ( 0.957 )	-6.95 ( 0.970 )	-6.70 ( 0.940 )	-7.30 ( 1.016 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Digit Span Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - Digit Span Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	-0.48 ( 0.185 )	-0.50 ( 0.189 )	-0.78 ( 0.184 )	-0.64 ( 0.193 )
Change to Week 48; n=101, 91, 105, 93	-0.75 ( 0.207 )	-0.65 ( 0.217 )	-0.41 ( 0.204 )	-0.65 ( 0.216 )
Change to Week 72; n=100, 92, 96, 95	-0.94 ( 0.194 )	-0.89 ( 0.201 )	-1.10 ( 2.105 )	-0.79 ( 0.199 )
Change to Week 96; n=81, 79, 85, 73	-1.07 ( 0.229 )	-0.81 ( 0.232 )	-0.83 ( 0.224 )	-0.90 ( 0.239 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Figure Copy Total Score

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End point title

Change From Baseline Over Time in RBANS - Figure Copy Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	0.29 ( 0.287 )	0.03 ( 0.293 )	-0.12 ( 0.284 )	-0.20 ( 0.299 )
Change to Week 48; n=102, 91, 105, 93	0.07 ( 0.363 )	-0.60 ( 0.380 )	-0.01 ( 0.359 )	-0.38 ( 0.379 )
Change to Week 72; n=100, 92, 97, 93	-0.57 ( 0.410 )	-0.77 ( 0.426 )	-1.04 ( 0.412 )	-1.25 ( 0.425 )
Change to Week 96; n=81, 79, 84, 74	-1.63 ( 0.470 )	-1.48 ( 0.480 )	-1.29 ( 0.462 )	-1.95 ( 0.490 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Figure Recall Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - Figure Recall Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=110, 106, 112, 102	-0.23 ( 0.259 )	-0.65 ( 0.264 )	0.06 ( 0.256 )	-0.60 ( 0.268 )
Change to Week 48; n=101, 91, 105, 92	-0.97 ( 0.276 )	-0.70 ( 0.288 )	-0.22 ( 0.272 )	-1.18 ( 0.288 )
Change to Week 72; n=99, 90, 97, 92	-1.21 ( 0.262 )	-1.16 ( 0.272 )	-0.68 ( 0.263 )	-1.45 ( 0.272 )
Change to Week 96; n=79, 77, 84, 73	-1.16 ( 0.299 )	-1.43 ( 0.305 )	-0.86 ( 0.293 )	-1.49 ( 0.310 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - List Recognition Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - List Recognition Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	0.09 ( 0.233 )	-0.64 ( 0.238 )	-0.38 ( 0.232 )	-0.79 ( 0.242 )
Change to Week 48; n=101, 91, 105, 93	0.31 ( 0.231 )	0.29 ( 0.242 )	0.41 ( 0.227 )	-0.23 ( 0.239 )
Change to Week 72; n=100, 92, 97, 94	0.13 ( 0.253 )	-0.55 ( 0.262 )	-0.48 ( 0.256 )	-0.43 ( 0.260 )
Change to Week 96; n=80, 79, 85, 74	-1.11 ( 0.279 )	-1.42 ( 0.281 )	-0.90 ( 0.271 )	-1.04 ( 0.289 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - List Learning Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - List Learning Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	-0.57 ( 0.350 )	-0.67 ( 0.359 )	-0.98 ( 0.348 )	-1.14 ( 0.364 )
Change to Week 48; n=102, 91, 105, 93	-1.27 ( 0.397 )	-0.36 ( 0.416 )	-1.89 ( 0.392 )	-1.17 ( 0.413 )
Change to Week 72; n=100, 92, 97, 95	-3.18 ( 0.413 )	-3.32 ( 0.428 )	-3.02 ( 0.415 )	-3.11 ( 0.424 )
Change to Week 96; n=82, 79, 87, 75	-3.57 ( 0.484 )	-2.93 ( 0.496 )	-3.23 ( 0.474 )	-3.07 ( 0.503 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Line Orientation Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - Line Orientation Total Score

End point description

The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 110, 102	0.20 ( 0.301 )	0.24 ( 0.308 )	-0.05 ( 0.301 )	0.03 ( 0.313 )
Change to Week 48; n=101, 91, 104, 92	-0.84 ( 0.348 )	0.05 ( 0.363 )	-0.53 ( 0.344 )	-0.47 ( 0.363 )
Change to Week 72; n=100, 92, 95, 94	-0.64 ( 0.365 )	-0.07 ( 0.378 )	-0.60 ( 0.369 )	-0.60 ( 0.377 )
Change to Week 96; n=77, 79, 84, 69	-1.33 ( 0.404 )	-1.01 ( 0.405 )	-0.99 ( 0.392 )	-1.88 ( 0.424 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - List Recall Total Score

Top of page

End point title

Change From Baseline Over Time in RBANS - List Recall Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	0.04 ( 0.102 )	-0.15 ( 0.105 )	-0.01 ( 0.102 )	-0.08 ( 0.106 )
Change to Week 48; n=101, 91, 105, 93	0.07 ( 0.120 )	0.05 ( 0.125 )	0.10 ( 0.118 )	-0.10 ( 0.124 )
Change to Week 72; n=100, 92, 97, 95	0.01 ( 0.081 )	-0.29 ( 0.084 )	-0.24 ( 0.082 )	-0.27 ( 0.083 )
Change to Week 96; n=80, 79, 86, 75	-0.14 ( 0.095 )	-0.39 ( 0.096 )	-0.35 ( 0.092 )	-0.31 ( 0.098 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Picture Naming Total Score

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End point title

Change From Baseline Over Time in RBANS - Picture Naming Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	-0.68 ( 0.132 )	-0.87 ( 0.136 )	-0.85 ( 0.132 )	-0.86 ( 0.138 )
Change to Week 48; n=101, 91, 105, 93	-0.21 ( 0.112 )	-0.10 ( 0.117 )	-0.09 ( 0.110 )	-0.14 ( 0.116 )
Change to Week 72; n=100, 92, 97, 95	-0.91 ( 0.162 )	-0.81 ( 0.168 )	-0.63 ( 0.163 )	-0.75 ( 0.167 )
Change to Week 96; n=81, 79, 87, 75	-0.68 ( 0.152 )	-0.94 ( 0.155 )	-0.65 ( 0.148 )	-0.77 ( 0.157 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

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End point title

Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 111, 102	-1.47 ( 0.289 )	-1.90 ( 0.296 )	-1.48 ( 0.288 )	-1.65 ( 0.300 )
Change to Week 48; n=101, 91, 105, 92	-1.03 ( 0.441 )	-1.00 ( 0.462 )	-0.90 ( 0.434 )	-0.79 ( 0.460 )
Change to Week 72; n=100, 92, 97, 95	-4.07 ( 0.462 )	-4.50 ( 0.480 )	-4.38 ( 0.465 )	-4.26 ( 0.475 )
Change to Week 96; n=81, 79, 87, 74	-2.29 ( 0.408 )	-2.87 ( 0.415 )	-2.83 ( 0.397 )	-2.78 ( 0.425 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Story Memory Total Score

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End point title

Change From Baseline Over Time in RBANS - Story Memory Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from __ to __, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	-3.06 ( 0.282 )	-3.13 ( 0.289 )	-2.93 ( 0.280 )	-2.99 ( 0.293 )
Change to Week 48; n=102, 91, 105, 93	-1.62 ( 0.324 )	-1.07 ( 0.341 )	-0.70 ( 0.320 )	-1.01 ( 0.338 )
Change to Week 72; n=100, 92, 97, 94	-2.15 ( 0.381 )	-2.00 ( 0.396 )	-1.84 ( 0.384 )	-2.10 ( 0.393 )
Change to Week 96; n=82, 79, 86, 74	-3.31 ( 0.380 )	-2.67 ( 0.388 )	-2.46 ( 0.372 )	-2.45 ( 0.397 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in RBANS - Story Recall Total Score

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End point title

Change From Baseline Over Time in RBANS - Story Recall Total Score

End point description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory – List Learning and Story Memory, 2. Visuospatial/Constructional – Figure Copy and Line Orientation, 3. Language – Picture naming and Semantic Fluency, 4. Attention – Digit Span and Coding, and 5. Delayed Memory – List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change to Week 24; n=111, 106, 112, 102	-0.93 ( 0.132 )	-1.01 ( 0.135 )	-0.93 ( 0.131 )	-0.95 ( 0.137 )
Change to Week 48; n=101, 91, 105, 93	-0.70 ( 0.178 )	-0.95 ( 0.186 )	-0.60 ( 0.175 )	-0.69 ( 0.137 )
Change to Week 72; n=100, 92, 97, 94	-0.90 ( 0.179 )	-1.12 ( 0.186 )	-0.90 ( 1.81 )	-1.38 ( 0.185 )
Change to Week 96; n=81, 79, 86, 74	-1.28 ( 0.197 )	-1.10 ( 0.201 )	-0.96 ( 0.192 )	-1.35 ( 0.205 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

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End point title

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

End point description

The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=111, 106, 113, 103	-0.60 ( 0.255 )	-0.83 ( 0.260 )	-0.48 ( 0.252 )	-1.56 ( 0.263 )
Change at Week 48; n=102, 92, 105, 92	-1.78 ( 0.294 )	-1.81 ( 0.305 )	-1.60 ( 0.290 )	-2.17 ( 0.305 )
Change at Week 72; n=100, 91, 97, 94	-2.83 ( 0.376 )	-2.92 ( 0.388 )	-2.43 ( 0.375 )	-3.34 ( 0.386 )
Change at Week 96; n=83, 81, 88, 76	-3.95 ( 0.478 )	-4.06 ( 0.488 )	-3.70 ( 0.469 )	-4.71 ( 0.494 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

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End point title

Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

End point description

The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=111, 105, 111, 101	0.93 ( 0.551 )	0.96 ( 0.567 )	0.80 ( 0.551 )	1.92 ( 0.576 )
Change at Week 48; n=104, 96, 107, 98	-0.03 ( 0.487 )	0.84 ( 0.505 )	0.99 ( 0.481 )	1.32 ( 0.502 )
Change at Week 72; n=102, 95, 100, 96	1.34 ( 0.742 )	1.52 ( 0.767 )	1.80 ( 0.745 )	3.25 ( 0.765 )
Change at Week 96; n=86, 86, 91, 82	2.38 ( 0.784 )	2.03 ( 0.794 )	2.53 ( 0.769 )	2.94 ( 0.804 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Secondary: Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

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End point title

Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

End point description

ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Endpoint 10) , MMSE (see description in Endpoint 45), and CDR-SB (see description in Endpoint 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable. Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. n=Participants with an assessment at given time point.

End point type

Secondary

End point timeframe

Baseline, Week 24, Week 48, Week 72, Week 96

End point values	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Number of subjects analysed	116	108	116	113
Units: score on a scale
least squares mean (standard error)
Change at Week 24; n=100, 98, 107, 95	0.05 ( 0.013 )	0.08 ( 0.013 )	0.05 ( 0.013 )	0.08 ( 0.014 )
Change at Week 48; n=89, 82, 99, 83	0.13 ( 0.018 )	0.15 ( 0.018 )	0.13 ( 0.017 )	0.13 ( 0.018 )
Change at Week 72; n=85, 79, 85, 84	0.22 ( 0.023 )	0.22 ( 0.024 )	0.22 ( 0.023 )	0.22 ( 0.024 )
Change at Week 96; n=72, 74, 79, 65	0.29 ( 0.029 )	0.29 ( 0.030 )	0.28 ( 0.029 )	0.35 ( 0.031 )

Attachments

Statistical Analyses

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Placebo

Reporting group description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 300 mg

Reporting group description

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 1000 mg

Reporting group description

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Reporting group title

ABBV-8E12 2000 mg

Reporting group description

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Serious adverse events	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Total subjects affected by serious adverse events
subjects affected / exposed	26 / 116 (22.41%)	19 / 108 (17.59%)	22 / 116 (18.97%)	17 / 113 (15.04%)
number of deaths (all causes)	1	2	2	1
number of deaths resulting from adverse events	1	2	2	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
BREAST CANCER METASTATIC
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
GASTROINTESTINAL STROMAL TUMOUR
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PROSTATIC ADENOMA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
HYPERTENSIVE CRISIS
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HYPOTENSION
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CHEST PAIN
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PYREXIA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	0 / 116 (0.00%)	2 / 108 (1.85%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
RESPIRATORY TRACT CONGESTION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
AGGRESSION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
AGITATION
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
DELIRIUM
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
MENTAL STATUS CHANGES
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SUICIDAL IDEATION
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
WEIGHT DECREASED
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
CHEST INJURY
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CLAVICLE FRACTURE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
FALL
subjects affected / exposed	3 / 116 (2.59%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
FEMUR FRACTURE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HIP FRACTURE
subjects affected / exposed	1 / 116 (0.86%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
MULTIPLE INJURIES
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PELVIC FRACTURE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMOTHORAX TRAUMATIC
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
RIB FRACTURE
subjects affected / exposed	2 / 116 (1.72%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ROAD TRAFFIC ACCIDENT
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SKIN LACERATION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SOFT TISSUE INJURY
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SPINAL COMPRESSION FRACTURE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SPINAL FRACTURE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SUBDURAL HAEMATOMA
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
TRAUMATIC INTRACRANIAL HAEMORRHAGE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
UPPER LIMB FRACTURE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
ATRIAL FIBRILLATION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ATRIAL FLUTTER
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
BRADYCARDIA
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
MYOCARDIAL INFARCTION
subjects affected / exposed	0 / 116 (0.00%)	2 / 108 (1.85%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
MYOCARDITIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
RIGHT VENTRICULAR FAILURE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
SINUS NODE DYSFUNCTION
subjects affected / exposed	1 / 116 (0.86%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
CEREBRAL HAEMORRHAGE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CEREBRAL MASS EFFECT
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	2 / 116 (1.72%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
DEMENTIA
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
DEMENTIA ALZHEIMER'S TYPE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ENCEPHALOPATHY
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HEADACHE
subjects affected / exposed	1 / 116 (0.86%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
MOTOR NEURONE DISEASE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
NORMAL PRESSURE HYDROCEPHALUS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PRESYNCOPE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SCIATICA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SEIZURE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	3 / 113 (2.65%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
THALAMUS HAEMORRHAGE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
ABDOMINAL PAIN
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CONSTIPATION
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
DYSPHAGIA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
GASTRIC ULCER HAEMORRHAGE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PANCREATITIS ACUTE
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SMALL INTESTINAL OBSTRUCTION
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
STOMACH MASS
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
VOMITING
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
URTICARIA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
NEPHROLITHIASIS
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
POLYURIA
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
RENAL FAILURE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
ARTHRITIS
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ATLANTOAXIAL SUBLUXATION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
CERVICAL SPINAL STENOSIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
NECK PAIN
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	0 / 116 (0.00%)	2 / 113 (1.77%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SPINAL OSTEOARTHRITIS
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
COVID-19
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19 PNEUMONIA
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
DIVERTICULITIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	2 / 113 (1.77%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ENDOCARDITIS
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
EPIGLOTTITIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ERYSIPELAS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
GASTROENTERITIS VIRAL
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	0 / 116 (0.00%)	2 / 108 (1.85%)	2 / 116 (1.72%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
PYELONEPHRITIS
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
SINUSITIS
subjects affected / exposed	0 / 116 (0.00%)	0 / 108 (0.00%)	1 / 116 (0.86%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	3 / 116 (2.59%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	1 / 116 (0.86%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
FAILURE TO THRIVE
subjects affected / exposed	0 / 116 (0.00%)	1 / 108 (0.93%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
HYPONATRAEMIA
subjects affected / exposed	2 / 116 (1.72%)	0 / 108 (0.00%)	0 / 116 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	ABBV-8E12 300 mg	ABBV-8E12 1000 mg	ABBV-8E12 2000 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	83 / 116 (71.55%)	68 / 108 (62.96%)	86 / 116 (74.14%)	91 / 113 (80.53%)
Injury, poisoning and procedural complications
CONTUSION
subjects affected / exposed	8 / 116 (6.90%)	6 / 108 (5.56%)	8 / 116 (6.90%)	5 / 113 (4.42%)
occurrences all number	10	7	8	6
FALL
subjects affected / exposed	22 / 116 (18.97%)	21 / 108 (19.44%)	17 / 116 (14.66%)	25 / 113 (22.12%)
occurrences all number	39	33	23	37
SKIN ABRASION
subjects affected / exposed	2 / 116 (1.72%)	7 / 108 (6.48%)	2 / 116 (1.72%)	1 / 113 (0.88%)
occurrences all number	5	8	2	2
SKIN LACERATION
subjects affected / exposed	6 / 116 (5.17%)	4 / 108 (3.70%)	6 / 116 (5.17%)	7 / 113 (6.19%)
occurrences all number	6	4	6	7
Vascular disorders
HYPERTENSION
subjects affected / exposed	2 / 116 (1.72%)	2 / 108 (1.85%)	6 / 116 (5.17%)	5 / 113 (4.42%)
occurrences all number	2	2	6	6
Nervous system disorders
HEADACHE
subjects affected / exposed	11 / 116 (9.48%)	9 / 108 (8.33%)	11 / 116 (9.48%)	20 / 113 (17.70%)
occurrences all number	12	11	15	29
DIZZINESS
subjects affected / exposed	10 / 116 (8.62%)	14 / 108 (12.96%)	9 / 116 (7.76%)	14 / 113 (12.39%)
occurrences all number	13	20	11	14
CEREBRAL MICROHAEMORRHAGE
subjects affected / exposed	4 / 116 (3.45%)	2 / 108 (1.85%)	6 / 116 (5.17%)	3 / 113 (2.65%)
occurrences all number	4	2	6	3
General disorders and administration site conditions
FATIGUE
subjects affected / exposed	11 / 116 (9.48%)	6 / 108 (5.56%)	7 / 116 (6.03%)	8 / 113 (7.08%)
occurrences all number	12	6	7	31
Immune system disorders
SEASONAL ALLERGY
subjects affected / exposed	6 / 116 (5.17%)	3 / 108 (2.78%)	2 / 116 (1.72%)	2 / 113 (1.77%)
occurrences all number	6	3	3	2
Gastrointestinal disorders
NAUSEA
subjects affected / exposed	2 / 116 (1.72%)	5 / 108 (4.63%)	4 / 116 (3.45%)	10 / 113 (8.85%)
occurrences all number	2	9	5	12
DIARRHOEA
subjects affected / exposed	9 / 116 (7.76%)	12 / 108 (11.11%)	10 / 116 (8.62%)	12 / 113 (10.62%)
occurrences all number	10	15	11	12
VOMITING
subjects affected / exposed	3 / 116 (2.59%)	5 / 108 (4.63%)	2 / 116 (1.72%)	11 / 113 (9.73%)
occurrences all number	4	5	2	14
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	7 / 116 (6.03%)	3 / 108 (2.78%)	7 / 116 (6.03%)	9 / 113 (7.96%)
occurrences all number	7	3	7	11
Psychiatric disorders
ANXIETY
subjects affected / exposed	11 / 116 (9.48%)	3 / 108 (2.78%)	9 / 116 (7.76%)	16 / 113 (14.16%)
occurrences all number	11	4	11	17
DEPRESSION
subjects affected / exposed	11 / 116 (9.48%)	10 / 108 (9.26%)	8 / 116 (6.90%)	12 / 113 (10.62%)
occurrences all number	11	10	10	13
INSOMNIA
subjects affected / exposed	3 / 116 (2.59%)	7 / 108 (6.48%)	2 / 116 (1.72%)	3 / 113 (2.65%)
occurrences all number	3	7	2	3
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	1 / 116 (0.86%)	0 / 108 (0.00%)	6 / 116 (5.17%)	2 / 113 (1.77%)
occurrences all number	1	0	9	2
BACK PAIN
subjects affected / exposed	7 / 116 (6.03%)	9 / 108 (8.33%)	11 / 116 (9.48%)	11 / 113 (9.73%)
occurrences all number	8	12	11	11
ARTHRALGIA
subjects affected / exposed	9 / 116 (7.76%)	7 / 108 (6.48%)	12 / 116 (10.34%)	10 / 113 (8.85%)
occurrences all number	11	7	14	12
Infections and infestations
INFLUENZA
subjects affected / exposed	0 / 116 (0.00%)	2 / 108 (1.85%)	3 / 116 (2.59%)	6 / 113 (5.31%)
occurrences all number	0	2	3	6
NASOPHARYNGITIS
subjects affected / exposed	11 / 116 (9.48%)	11 / 108 (10.19%)	12 / 116 (10.34%)	12 / 113 (10.62%)
occurrences all number	12	12	16	14
BRONCHITIS
subjects affected / exposed	6 / 116 (5.17%)	0 / 108 (0.00%)	1 / 116 (0.86%)	3 / 113 (2.65%)
occurrences all number	6	0	1	3
SINUSITIS
subjects affected / exposed	8 / 116 (6.90%)	0 / 108 (0.00%)	3 / 116 (2.59%)	3 / 113 (2.65%)
occurrences all number	10	0	3	4
URINARY TRACT INFECTION
subjects affected / exposed	12 / 116 (10.34%)	11 / 108 (10.19%)	13 / 116 (11.21%)	11 / 113 (9.73%)
occurrences all number	17	12	16	11
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	9 / 116 (7.76%)	7 / 108 (6.48%)	12 / 116 (10.34%)	18 / 113 (15.93%)
occurrences all number	13	11	14	19

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

19 Mar 2018

The purpose of this amendment is to include the new ABBV-8E12 formulation, addition of tau positron emission tomography (PET) and retinal imaging assessments and update the treatments administered section. Other revisions were made to ensure consistency within the protocol and to provide further clarifications of study design and processes.

15 Nov 2018

The purpose of this amendment is to: ● Update Section 4.0, Study Objectives, to add an exploratory objective for a digital clock drawing test. ● Update Section 5.1, Overall Study Design and Plan, to add Japan in the study. ● Update Section 5.3.1.1, Study Procedures, and Appendix C, Study Activities, to clarify the current diagnostic tools and scale order and duration (Table 4) and include additional study activities. ● Update Section 5.5.1, Treatment Administered, to define the study drug infusion rate during the study. ● Update Section 8.1.3, Efficacy Analyses, to revise multiplicity control method to incorporate the development goals. ● Update Section 8.1.10, Interim Analysis, to include target engagement interim analysis for the first 48 Cohort 1 subjects.

02 Oct 2020

The purpose of this amendment is to: ● Update Section 3.2 Benefits and Risks to include language for the coronavirus disease-19 (COVID-19) pandemic. ● Update Section 5.1 Overall Study Design and Plan: Description to remove sites in Japan from the study. ● Update Section 5.3.1.1 Study Procedures [Physical Examination, Neurological Examination, Vital Signs, 12-Lead Electrocardiogram (ECG), Abnormal Findings, Lumbar Puncture (LP), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) Tau Imaging, Retinal Imaging for Amyloid, and Digital Clock Drawing Test (dCDT)] to include language for the COVID-19 pandemic. ● Update Section 5.3.1.2 Collection and Handling of Biomarker and Pharmacogenetic Research Samples [Apolipoprotein E (APOE) Pharmacogenetic Sample; Optional Pharmacogenetic Research Samples] to include language for the COVID-19 pandemic. ● Update Section 5.4.1 Discontinuation of Individual Subjects to include language for the COVID-19 pandemic. ● Update Section 5.5.1 Treatments Administered to include language for the COVID-19 pandemic. ● Update Section 6.1.5 Adverse Event Reporting to include language for the COVID-19 pandemic. ● Update Section 8.1.7.1 Tabulations and Summary Statistics to include summary of data for all subjects ● Update Section 9.2 Ethical Conduct of the Study to include language for the COVID-19 pandemic. ● Update Section 9.3 Subject Information and Consent to include language for the COVID-19 pandemic. ● Update Section 11.0 Data Quality Assurance to include language for the COVID-19 pandemic. ● Update footnote at Appendix C Study Activities to accommodate tau PET due to scheduling conflicts.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline Over Time in CDR-SB Score

Primary: Change From Baseline Over Time in CDR-SB Score

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Secondary: Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Secondary: Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADASCog- 14) Total Score

Secondary: Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADASCog- 14) Total Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Commands Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Commands Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Secondary: Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Secondary: Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Secondary: Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Secondary: Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

Secondary: Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

Secondary: Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

Secondary: Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

Secondary: Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

Secondary: Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

Secondary: Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

Secondary: Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

Secondary: Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

Secondary: Change From Baseline Over Time in RBANS - Coding Total Score

Secondary: Change From Baseline Over Time in RBANS - Coding Total Score

Secondary: Change From Baseline Over Time in RBANS - Digit Span Total Score

Secondary: Change From Baseline Over Time in RBANS - Digit Span Total Score

Secondary: Change From Baseline Over Time in RBANS - Figure Copy Total Score

Secondary: Change From Baseline Over Time in RBANS - Figure Copy Total Score

Clinical Trial Results:
A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease