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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

    Summary
    EudraCT number
    		 2011-004849-40
    Trial protocol
    		 GR   DE   GB  
    Global end of trial date
    24 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    10 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M11-793
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01549834
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Laura Gault, MD, AbbVie, laura.gault@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of 2 doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking stable doses of acetylcholinesterase inhibitors (AChEIs).
    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
    09 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 56
    Country: Number of subjects enrolled
    France: 49
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Greece: 79
    Country: Number of subjects enrolled
    South Africa: 44
    Country: Number of subjects enrolled
    Canada: 57
    Country: Number of subjects enrolled
    United States: 109
    Worldwide total number of subjects
    434
    EEA total number of subjects
    224
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    43
    From 65 to 84 years
    346
    85 years and over
    45

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a Screening period of up to 28 days. A total of 565 subjects were screened.

    Period 1
    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, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Three placebo capsules once daily in the morning for 24 weeks beginning on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered orally as capsules

    Arm title
    		 ABT-126 25 mg QD
    Arm description
    		 One ABT-126 25 mg capsule and 2 placebo capsules once daily in the morning for 24 weeks beginning on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-126
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-126 administered orally as capsules

    Arm title
    		 ABT-126 75 mg QD
    Arm description
    		 Three ABT-126 25 mg capsules once daily in the morning for 24 weeks beginning on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-126
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-126 administered orally as capsules

    Number of subjects in period 1
    		Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Started
    146
    143
    145
    Completed
    129
    126
    122
    Not completed
    17
    17
    23
         Consent withdrawn by subject
    5
    2
    4
         Adverse event
    9
    7
    11
         Other (not specified)
    1
    5
    3
         Lost to follow-up
    1
    1
    2
         Lack of efficacy
    1
    -
    -
         Noncompliance
    -
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Three placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 One ABT-126 25 mg capsule and 2 placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 Three ABT-126 25 mg capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD Total
    Number of subjects
    		 146 143 145 434
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 75.1 ( 6.86 ) 74.6 ( 8.39 ) 75.6 ( 7.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 72 78 87 237
        Male
    		 74 65 58 197

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Three placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 One ABT-126 25 mg capsule and 2 placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 Three ABT-126 25 mg capsules once daily in the morning for 24 weeks beginning on Day 1.

    Primary: Alzheimer's Disease Assessment Scale – Cognitive Scale (ADAS-Cog) 11-item Total Score: Change from Baseline to Week 24

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    End point title
    		 Alzheimer's Disease Assessment Scale – Cognitive Scale (ADAS-Cog) 11-item Total Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The ADAS-Cog 11-item total score is the sum of the following 11 items: Word Recall, Commands, Constructional Praxis, Naming Objects and Fingers, Ideational Praxis, Orientation, Word Recognition, Remembering Test Instructions, Comprehension of Spoken Language, Spoken Language Ability, and Word Finding Difficulty. The ADAS-Cog 11-item total score ranges from 0 to 70 with a lower score desirable. A decrease in the total score indicates improvement, with a higher score indicating greater cognitive impairment.
    End point type
    Primary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    128 [1]
    124 [2]
    121 [3]
    Units: units on a scale
        least squares mean (standard error)
    1.37 ( 0.42 )
    0.57 ( 0.43 )
    1.25 ( 0.43 )
    Notes
    [1] - Subjects with a baseline and at least one post baseline assessment
    [2] - Subjects with a baseline and at least one post baseline assessment
    [3] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    ABT-126 25 mg QD v Placebo
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.087
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.59
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.416
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.59

    Secondary: ADAS-Cog 13-item Total Score: Change from Baseline to Week 24

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    End point title
    		 ADAS-Cog 13-item Total Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The ADAS-Cog 13-item total score is the sum of the following 13 items: Word Recall, Commands, Constructional Praxis, Naming Objects and Fingers, Ideational Praxis, Orientation, Word Recognition, Remembering Test Instructions, Comprehension of Spoken Language, Spoken Language Ability, Word Finding Difficulty, and Delayed Word Recall, and Number Cancellation Test. The ADAS-Cog 13-item total score ranges from 0 to 85 with a lower score desirable. A decrease in the total score indicates improvement, with a higher score indicating greater cognitive impairment.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    125 [4]
    123 [5]
    119 [6]
    Units: units on a scale
        least squares mean (standard error)
    1.18 ( 0.48 )
    0.44 ( 0.48 )
    1.23 ( 0.49 )
    Notes
    [4] - Subjects with a baseline and at least one post baseline assessment
    [5] - Subjects with a baseline and at least one post baseline assessment
    [6] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.135
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 0.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.67
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.525
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 1.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.68

    Secondary: Mini-Mental Status Exam (MMSE) Score: Change from Baseline to Week 24

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    End point title
    		 Mini-Mental Status Exam (MMSE) Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The MMSE is a brief questionnaire administered by a trained rater that provides a quantitative measure of cognitive status in adults used to estimate the severity of cognitive impairment. The MMSE score ranges from 0 to 30 points, with a lower score indicating greater cognitive impairment and an increase from baseline indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    129 [7]
    125 [8]
    122 [9]
    Units: units on a scale
        least squares mean (standard error)
    -0.27 ( 0.27 )
    -0.49 ( 0.27 )
    -0.45 ( 0.27 )
    Notes
    [7] - Subjects with a baseline and at least one post baseline assessment
    [8] - Subjects with a baseline and at least one post baseline assessment
    [9] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.721
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.679
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38

    Secondary: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score: Change from Baseline to Week 24

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    End point title
    		 Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The ADCS-ADL is a 23-item (question) caregiver-based assessment of activities of daily living designed specifically for AD patients. The scale assesses functional activities such as eating, bathing, grooming, 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 range from 0 to 78, with lower scores indicating more severe impairment and an increase from baseline indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    130 [10]
    124 [11]
    123 [12]
    Units: units on a scale
        least squares mean (standard error)
    -2.58 ( 0.63 )
    -3 ( 0.64 )
    -3.7 ( 0.64 )
    Notes
    [10] - Subjects with a baseline and at least one post baseline assessment
    [11] - Subjects with a baseline and at least one post baseline assessment
    [12] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.68
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.41
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.87
         upper limit
    		 1.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.895
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -1.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.57
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89

    Secondary: DEMentia Quality of Life (DEMQOL) Subject Total Score: Change from Baseline to Week 24

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    End point title
    		 DEMentia Quality of Life (DEMQOL) Subject Total Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The DEMQOL measures of health-related quality of life in dementia are appropriate for use in mild-to-moderate stages of dementia severity. The DEMQOL contains 28 items and covers 4 domains: daily activities and looking after oneself, health and well-being, cognitive functioning, and social relationships. The recall period is 1 week. Items are scored on a 4-point Likert scale, resulting in a global score ranging from 28 to 112. Higher scores indicate better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    130 [13]
    122 [14]
    121 [15]
    Units: units on a scale
        least squares mean (standard error)
    1.6 ( 0.81 )
    1.46 ( 0.83 )
    1.24 ( 0.84 )
    Notes
    [13] - Subjects with a baseline and at least one post baseline assessment
    [14] - Subjects with a baseline and at least one post baseline assessment
    [15] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.547
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.01
         upper limit
    		 1.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.14
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    ABT-126 75 mg QD v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.625
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 1.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.14

    Secondary: Clinician Interview-Based Impression of Change-Plus (CIBIC-plus): Change from Baseline to Week 24

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    End point title
    		 Clinician Interview-Based Impression of Change-Plus (CIBIC-plus): Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The CIBIC-plus captures a global impression of change in severity of dementia using 4 major areas of assessment: general functioning, cognitive functioning, behavioral functioning, and activities of daily living. A 7-point scale is used to score the CIBIC-plus in which 1 of the following is selected: 1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, or 7=markedly worse. The Clinician Interview-Based Impression of Severity (CIBIS) Score was administered on Day -1 (baseline). Missing data were imputed by Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    129 [16]
    124 [17]
    121 [18]
    Units: units on a scale
        least squares mean (standard error)
    4.28 ( 0.07 )
    4.48 ( 0.07 )
    4.45 ( 0.07 )
    Notes
    [16] - Subjects with a baseline and at least one post baseline assessment
    [17] - Subjects with a baseline and at least one post baseline assessment
    [18] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.976
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.957
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Neuropsychiatry Inventory (NPI) 12-Item Total Score: Change from Baseline to Week 24

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    End point title
    		 Neuropsychiatry Inventory (NPI) 12-Item Total Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The NPI assesses 10 behavioral domains and 2 neurovegetative domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0=absent, 1=occasionally, 2=often, 3=frequently, and 4=very frequently. Severity is rated on a scale where 0=absent, 1=mild, 2=moderate, and 3=marked. Distress is rated on a scale where 0 = not at all, 1=minimally, 2=mildly, 3=moderately, 4=severely, and 5=very severely or extremely. For each of the behavioral domains, 4 scores were obtained: frequency, severity, distress, and total (product of frequency and severity; range from 0 to 12). The 12-item NPI total score is the sum of the 10 behavioral domains and the 2 neurovegetative domains (scores range from 0 to 144 with a lower score desirable).
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    130 [19]
    125 [20]
    123 [21]
    Units: units on a scale
        least squares mean (standard error)
    1.37 ( 0.85 )
    1.22 ( 0.86 )
    1.87 ( 0.87 )
    Notes
    [19] - Subjects with a baseline and at least one post baseline assessment
    [20] - Subjects with a baseline and at least one post baseline assessment
    [21] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.451
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 1.83
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.662
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 2.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Secondary: Partner-Patient Questionnaire for Shared Activities (PPQSA) Average Score: Change from Baseline to Week 24

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    End point title
    		 Partner-Patient Questionnaire for Shared Activities (PPQSA) Average Score: Change from Baseline to Week 24
    End point description
    From repeated measures analysis. The PPQSA is a caregiver-completed assessment to measure the extent to which the AD patient's mood and mental state interferes with the patient-partner (i.e., patient-caregiver, patient-spouse, or patient-non-spouse partner) relationship. The scale consists of 17 shared activity items, a global interference item, and a ranking of the 5 most important activities. The scale is scored by taking a simple average of the items. Scores range from 0 to 5 with a higher score desirable.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    129 [22]
    125 [23]
    123 [24]
    Units: units on a scale
        least squares mean (standard error)
    -0.02 ( 0.06 )
    -0.07 ( 0.06 )
    -0.02 ( 0.06 )
    Notes
    [22] - Subjects with a baseline and at least one post baseline assessment
    [23] - Subjects with a baseline and at least one post baseline assessment
    [24] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.721
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with fixed effects of treatment, site, visit, and baseline score; interactions of treatment by visit and baseline score by visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.493
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Resource Use in Dementia (RUD-Lite) Caregiver Time Score: Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 Resource Use in Dementia (RUD-Lite) Caregiver Time Score: Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The RUD-Lite is a brief measure of resource utilization developed for use in clinical trials of AD and is completed by non-professional caregivers in the study. The caregiver time scores range from 0 to 1440 with a lower score desirable.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24)
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    123 [25]
    120 [26]
    114 [27]
    Units: units on a scale
        least squares mean (standard error)
    38.01 ( 14.14 )
    32.33 ( 14.27 )
    38.02 ( 14.6 )
    Notes
    [25] - Subjects with a baseline and at least one post baseline assessment
    [26] - Subjects with a baseline and at least one post baseline assessment
    [27] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.384
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    -5.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -37.53
         upper limit
    		 26.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    19.31
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -32.29
         upper limit
    		 32.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    19.58

    Secondary: EuroQol-5 Dimension Questionnaire (EQ-5D-5L) Index Score: Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 EuroQol-5 Dimension Questionnaire (EQ-5D-5L) Index Score: Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The EQ-5D-5L is a 5-dimensional tool capturing subjects' mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Subjects rate each dimension using a scale with 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem. Subjects also rate their perception of their overall health on a visual analogue scale (VAS). EQ-5D-5L scores are derived by converting raw scores based on the Administration and Scoring Manual. The EQ-5D-5L Index Score ranges from -0.11 to 1 with a higher score desirable. The higher the score, the better the subject's health condition.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24)
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    133 [28]
    126 [29]
    125 [30]
    Units: units on a scale
        least squares mean (standard error)
    0 ( 0.01 )
    0 ( 0.01 )
    0 ( 0.01 )
    Notes
    [28] - Subjects with a baseline and at least one post baseline assessment
    [29] - Subjects with a baseline and at least one post baseline assessment
    [30] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    ABT-126 25 mg QD v Placebo
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.534
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.72
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01

    Secondary: EuroQol-3 Dimension Questionnaire (EQ-5D-3L) Proxy Index Score: Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 EuroQol-3 Dimension Questionnaire (EQ-5D-3L) Proxy Index Score: Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The EQ-5D-3L is a 5-dimensional tool capturing subjects' mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Proxies (e.g., caregivers) rate ach dimension using a scale with 3 levels, where 3 represents no problem, 2 represents some problem, and 1 represents extreme problem, based on how he or she (the caregiver) believes that the subject would rate their own health-related quality of life if they were able to communicate it. Proxies also rate the overall health of the subject on a visual analogue scale (VAS). EQ-5D-3L scores are derived by converting raw scores based on the Administration and Scoring Manual. The EQ-5D-3L Index Score ranges from -0.11 to 1 with a higher score desirable. The higher the score, the better the subject's health condition.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    134 [31]
    128 [32]
    126 [33]
    Units: units on a scale
        least squares mean (standard error)
    -0.02 ( 0.01 )
    0.01 ( 0.01 )
    -0.02 ( 0.01 )
    Notes
    [31] - Subjects with a baseline and at least one post baseline assessment
    [32] - Subjects with a baseline and at least one post baseline assessment
    [33] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.071
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.605
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Wechsler Memory Scale-III (WMS-III) Working Memory Index: Change from Baseline through Week 18

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    End point title
    		 Wechsler Memory Scale-III (WMS-III) Working Memory Index: Change from Baseline through Week 18
    End point description
    The WMS-III Working Memory Index Score includes the Letter Number Sequencing (LNS) and Spatial Span (SS) tests. The LNS is a memory test in which the subjects are read a combination of letters and numbers and are asked to repeat them, saying the numbers in ascending order followed by the letters in alphabetical order. The LNS score ranges from 0 to 21 points. The SS is a measure of nonverbal working memory, with scores that range from 0 to 32. Raw scores from both LNS and SS are converted to scaled scores using the WMS-III Administration and Scoring Manual and the overall Working Memory Index is derived from these scaled scores. The WMS-III Working Memory Index ranges from 49 to 155. Higher scores and higher Working Memory Index are desirable.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 18
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    130 [34]
    131 [35]
    124 [36]
    Units: units on a scale
        least squares mean (standard error)
    -2.05 ( 0.79 )
    -1.7 ( 0.8 )
    -1.8 ( 0.81 )
    Notes
    [34] - Subjects with a baseline and at least one post baseline assessment
    [35] - Subjects with a baseline and at least one post baseline assessment
    [36] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.376
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 2.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.412
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 2.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.11

    Secondary: Wechsler Memory Scale-III (WMS-III) Letter Number Sequencing (LNS) Scaled Score: Change from Baseline through Week 18

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    End point title
    		 Wechsler Memory Scale-III (WMS-III) Letter Number Sequencing (LNS) Scaled Score: Change from Baseline through Week 18
    End point description
    From repeated measures analysis. The WMS-III Letter Number Sequencing (LNS) test is a memory test in which the subjects are read a combination of letters and numbers and are asked to repeat them, saying the numbers in ascending order followed by the letters in alphabetical order. Raw scores from LNS are converted to scaled scores using the WMS-III Administration and Scoring Manual. The WMS-III LNS Scaled Score ranges from 1 to 19 with a higher score desirable.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 18
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    130 [37]
    131 [38]
    124 [39]
    Units: units on a scale
        least squares mean (standard error)
    -0.24 ( 0.2 )
    -0.37 ( 0.21 )
    -0.05 ( 0.21 )
    Notes
    [37] - Subjects with a baseline and at least one post baseline assessment
    [38] - Subjects with a baseline and at least one post baseline assessment
    [39] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.677
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.252
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29

    Secondary: Wechsler Memory Scale-III (WMS-III) Spatial Span (SS) Scaled Score: Change from Baseline through Week 18

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    End point title
    		 Wechsler Memory Scale-III (WMS-III) Spatial Span (SS) Scaled Score: Change from Baseline through Week 18
    End point description
    From repeated measures analysis. The WMS-III Spatial Span (SS) test is a measure of nonverbal working memory. Raw scores from SS are converted to scaled scores using the WMS-III Administration and Scoring Manual. The WMS-III SS Scaled Score ranges from 1 to 19 with a higher score desirable.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 18
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    131 [40]
    133 [41]
    125 [42]
    Units: units on a scale
        least squares mean (standard error)
    -0.6 ( 0.2 )
    -0.16 ( 0.2 )
    -0.62 ( 0.21 )
    Notes
    [40] - Subjects with a baseline and at least one post baseline assessment
    [41] - Subjects with a baseline and at least one post baseline assessment
    [42] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.057
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    0.45
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    One-sided P value from repeated measures model with treatment, site, visit, baseline score, interactions of treatment and visit; baseline score and visit; covariance structure is unstructured.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.526
    Method
    		 mixed-effects model for repeated measure
    Parameter type
    		 LS mean of difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29

    Secondary: Cornell Scale for Depression in Dementia (CSDD): Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 Cornell Scale for Depression in Dementia (CSDD): Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The CSDD is a 19-item interviewer-rated scale for assessing the signs and symptoms of major depression in patients with dementia. Information is obtained from 2 semi-structured interviews: an interview with the subject and an interview with the caregiver. Each item is ranked on a severity scale of 0 to 2 (0 = absent; 1 = mild or intermittent; 2 = severe). The individual item scores are summed for a total score. The CSDD scores range from 0 to 38, with higher scores indicative of greater depression; scores above 10 indicate a probable major depression. Subjects with scores of above 10 at Screening Visit 1 were excluded from the study.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24)
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    133 [43]
    127 [44]
    125 [45]
    Units: units on a scale
        least squares mean (standard error)
    -0.35 ( 0.21 )
    -0.31 ( 0.22 )
    -0.23 ( 0.22 )
    Notes
    [43] - Subjects with a baseline and at least one post baseline assessment
    [44] - Subjects with a baseline and at least one post baseline assessment
    [45] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.552
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.655
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Number of Subjects in Each Category of the Clinician Interview-Based Impression of Change-Plus (CIBIC-plus) at Week 24

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    End point title
    		 Number of Subjects in Each Category of the Clinician Interview-Based Impression of Change-Plus (CIBIC-plus) at Week 24
    End point description
    The CIBIC-plus is designed to capture a global impression of change in severity of dementia using 4 major areas of assessment: general functioning, cognitive functioning, behavioral functioning, and activities of daily living. The CIBIC-plus and the CIBIS were performed by a trained rater who did not have access to the results of other study assessments or medical records for the subject and who did not participate in the care or management of the subject. A 7-point scale is used to score the CIBIC-plus in which 1 of the following is selected: 1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6 = moderately worse, or 7 = markedly worse. CIBIC-plus scores were stratified by Clinician Interview-Based Impression of Severity (CIBIS) Score at baseline. Subjects who did not reach Week 24 were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    142
    137
    137
    Units: subjects
        Markedly improved
    0
    0
    0
        Moderately improved
    3
    0
    2
        Minimally improved
    21
    11
    14
        No change
    66
    64
    57
        Minimally worse
    39
    50
    52
        Moderately worse
    12
    11
    12
        Markedly worse
    1
    1
    0
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.066
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.089
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: EuroQol-5 Dimension Questionnaire (EQ-5D-5L) Health State Score: Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 EuroQol-5 Dimension Questionnaire (EQ-5D-5L) Health State Score: Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The EQ-5D-5L is a 5-dimensional tool capturing subjects' mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Subjects rate each dimension using a scale with 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem. Subjects also rate their perception of their overall health on a visual analogue scale (VAS). EQ-5D-5L scores are derived by converting raw scores based on the Administration and Scoring Manual. The EQ-5D-5L Health State Score ranges from 0 to 100 with a higher score desirable. The higher the score, the better the subject's health condition.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24)
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    133 [46]
    124 [47]
    125 [48]
    Units: units on a scale
        least squares mean (standard error)
    -2.51 ( 1.22 )
    -1.87 ( 1.27 )
    0.6 ( 1.27 )
    Notes
    [46] - Subjects with a baseline and at least one post baseline assessment
    [47] - Subjects with a baseline and at least one post baseline assessment
    [48] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    ABT-126 25 mg QD v Placebo
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.354
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    0.64
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.18
         upper limit
    		 3.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.71
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.035
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    3.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 5.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.71

    Secondary: EuroQol-3 Dimension Questionnaire (EQ-5D-3L) Proxy Health State Score: Change from Baseline to Final Evaluation (up to Week 24)

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    End point title
    		 EuroQol-3 Dimension Questionnaire (EQ-5D-3L) Proxy Health State Score: Change from Baseline to Final Evaluation (up to Week 24)
    End point description
    The EQ-5D-3L is a 5-dimensional tool capturing subjects' mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Proxies (e.g., caregivers) rate ach dimension using a scale with 3 levels, where 3 represents no problem, 2 represents some problem, and 1 represents extreme problem, based on how he or she (the caregiver) believes that the subject would rate their own health-related quality of life if they were able to communicate it. Proxies also rate the overall health of the subject on a visual analogue scale (VAS). EQ-5D-3L scores are derived by converting raw scores based on the Administration and Scoring Manual. The EQ-5D-3L Health State Score ranges from 0 to 100 with a higher score desirable. The higher the score, the better the subject's health condition.
    End point type
    Secondary
    End point timeframe
    Baseline through Final Evaluation (up to Week 24
    End point values
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Number of subjects analysed
    133 [49]
    128 [50]
    126 [51]
    Units: units on a scale
        least squares mean (standard error)
    -0.49 ( 1.34 )
    -2.23 ( 1.36 )
    -2.01 ( 1.38 )
    Notes
    [49] - Subjects with a baseline and at least one post baseline assessment
    [50] - Subjects with a baseline and at least one post baseline assessment
    [51] - Subjects with a baseline and at least one post baseline assessment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 25 mg QD
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.824
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    -1.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.81
         upper limit
    		 1.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.86
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    ANCOVA model with change from baseline to the final visit as the response, treatment and study site as the main effects, and the baseline value as the covariate.
    Comparison groups
    Placebo v ABT-126 75 mg QD
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.792
    Method
    		 ANCOVA
    Parameter type
    		 LS mean of difference
    Point estimate
    -1.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 1.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.87

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from study drug administration until 30 days following last dose (28 weeks); SAEs were collected from when informed consent was obtained (32 weeks).
    Adverse event reporting additional description
    All AEs were collected whether solicited or spontaneously reported by the subject
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Three placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 25 mg QD
    Reporting group description
    		 One ABT-126 25 mg capsule and 2 placebo capsules once daily in the morning for 24 weeks beginning on Day 1.

    Reporting group title
    ABT-126 75 mg QD
    Reporting group description
    		 Three ABT-126 25 mg capsules once daily in the morning for 24 weeks beginning on Day 1.

    Serious adverse events
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 146 (8.90%)
    9 / 143 (6.29%)
    10 / 145 (6.90%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo ABT-126 25 mg QD ABT-126 75 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 146 (25.34%)
    38 / 143 (26.57%)
    52 / 145 (35.86%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    11 / 146 (7.53%)
    9 / 143 (6.29%)
    13 / 145 (8.97%)
         occurrences all number
    12
    14
    15
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 146 (2.05%)
    5 / 143 (3.50%)
    8 / 145 (5.52%)
         occurrences all number
    3
    6
    10
    Headache
         subjects affected / exposed
    4 / 146 (2.74%)
    10 / 143 (6.99%)
    9 / 145 (6.21%)
         occurrences all number
    4
    11
    10
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 146 (1.37%)
    7 / 143 (4.90%)
    12 / 145 (8.28%)
         occurrences all number
    3
    8
    16
    Diarrhoea
         subjects affected / exposed
    7 / 146 (4.79%)
    11 / 143 (7.69%)
    6 / 145 (4.14%)
         occurrences all number
    7
    11
    6
    Nausea
         subjects affected / exposed
    2 / 146 (1.37%)
    3 / 143 (2.10%)
    11 / 145 (7.59%)
         occurrences all number
    2
    6
    12
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    6 / 146 (4.11%)
    5 / 143 (3.50%)
    9 / 145 (6.21%)
         occurrences all number
    8
    5
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 146 (6.16%)
    0 / 143 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    9
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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