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    Clinical Trial Results:
    Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

    Summary
    EudraCT number
    2012-000537-39
    Trial protocol
    GB   DE   GR  
    Global end of trial date
    24 Feb 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    18 May 2016
    First version publication date
    11 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    new version being created so writer can re-gain access to the published study to re-confirm that study has no errors.

    Trial information

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    Trial identification
    Sponsor protocol code
    M11-428
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01690195
    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, PhD, 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 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of acetylcholinesterase inhibitors (AChEIs) in a 28-week open-label extension of study 2011-004849-40 (M11-793).
    Protection of trial subjects
    Participant 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
    20 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 46
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    South Africa: 41
    Country: Number of subjects enrolled
    United Kingdom: 44
    Country: Number of subjects enrolled
    France: 37
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Greece: 62
    Worldwide total number of subjects
    343
    EEA total number of subjects
    174
    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)
    33
    From 65 to 84 years
    276
    85 years and over
    34

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Only subjects randomized into study 2011-004849-40 who completed dosing through Week 24 of that study were eligible for study 2012-000537-39. Each subject had routine safety procedures/clinical laboratory tests performed either on Day –1 or as part of the 2011-004849-40 Week 24 visit. Subjects who met the selection criteria were entered into study.

    Pre-assignment period milestones
    Number of subjects started
    343
    Number of subjects completed
    342

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    randomized but not treated: 1
    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    ABT-126
    Arm description
    ABT-126 25 mg hard gelatin capsule administered orally beginning at 75 mg once daily (QD), which could have been adjusted downward in 25 mg increments with the permission of the AbbVie medical monitor for safety or tolerability issues.
    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
    The allowable total daily dose of ABT-126 was 25 mg to 75 mg.

    Number of subjects in period 1 [1]
    ABT-126
    Started
    342
    Completed
    173
    Not completed
    169
         Study terminated prematurely
             135
         Adverse event
             13
         Noncompliance
             4
         Lack of efficacy
             6
         Not specified
             4
         Consent withdrawn by subject
             6
         Lost to follow-up
             1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was randomized but not treated, and is not included in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    ABT-126 25 mg hard gelatin capsule administered orally beginning at 75 mg once daily (QD), which could have been adjusted downward in 25 mg increments with the permission of the AbbVie medical monitor for safety or tolerability issues.

    Reporting group values
    Overall study Total
    Number of subjects
    342 342
    Age categorical
    Units: Subjects
        < 75 years
    150 150
        >= 75 years
    192 192
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    75.1 ± 7.62 -
    Gender categorical
    Units: Subjects
        Female
    191 191
        Male
    151 151

    End points

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    End points reporting groups
    Reporting group title
    ABT-126
    Reporting group description
    ABT-126 25 mg hard gelatin capsule administered orally beginning at 75 mg once daily (QD), which could have been adjusted downward in 25 mg increments with the permission of the AbbVie medical monitor for safety or tolerability issues.

    Primary: Number of Subjects With Treatment-emergent Adverse Events

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    End point title
    Number of Subjects With Treatment-emergent Adverse Events [1]
    End point description
    A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened in severity on or after the first day of ABT-126 dosing in Study 2012-000537-39 (M11-428) and no more than 30 days after the last study drug dose date.
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation) of treatment plus 30 days. Mean (SD) number of treatment exposure days was 163.4 (± 45.37).
    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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    342
    Units: subjects
        Any adverse event (AE)
    196
        AE w/reasonable possibility of relatedness to drug
    55
        Any severe AE
    24
        Any serious AE
    30
        AE leading to discontinuation of study
    19
        Any fatal AE
    2
        Deaths, including non-treatment-emergent deaths
    2
    No statistical analyses for this end point

    Primary: Number of Subjects Meeting Criteria for Potentially Clinically Significant Hematology Values

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    End point title
    Number of Subjects Meeting Criteria for Potentially Clinically Significant Hematology Values [2]
    End point description
    F=female, M=male
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation).
    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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    341 [3]
    Units: subjects
        Lymphocytes < 0.75*10^9/L
    13
        White blood cell count < 2.8*10^9/L
    5
        Neutrophils < 1.2*10^9/L
    4
        Hemoglobin < 90 g/L (F) or < 100 g/L (M)
    1
    Notes
    [3] - subjects with post-baseline values for each parameter
    No statistical analyses for this end point

    Primary: Number of Subjects Meeting Criteria for Potentially Clinically Significant Chemistry Values

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    End point title
    Number of Subjects Meeting Criteria for Potentially Clinically Significant Chemistry Values [4]
    End point description
    ULN=upper limit of normal, F=female, M=male
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation).
    Notes
    [4] - 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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    341 [5]
    Units: subjects
        Blood Urea Nitrogen > 156 mmol/L
    4
        Creatinine > 159 (F) or > 180 (M) μmol/L
    4
        Total bilirubin > 29 μmol/L
    4
        Uric acid > 500 (F) or > 590 (M) μmol/L
    4
        Alanine aminotransferase > 3*ULN
    1
        Aspartate aminotransferase > 3*ULN
    1
        Glucose < 2.75 mmol/L
    1
        Glucose > 16.5 mmol/L
    1
        Inorganic phosphate < 0.54 mmol/L
    1
        Potassium < 3 mmol/L
    1
        Potassium > 6 mmol/L
    1
        Total protein < 45 g/L
    1
    Notes
    [5] - subjects with post-baseline values for each parameter
    No statistical analyses for this end point

    Primary: Number of Subjects Meeting Criteria for Potentially Clinically Significant Vital Sign and Weight Values

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    End point title
    Number of Subjects Meeting Criteria for Potentially Clinically Significant Vital Sign and Weight Values [6]
    End point description
    SBP=systolic blood pressure, DBP=diastolic blood pressure, bpm=beats per minute
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation).
    Notes
    [6] - 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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    341 [7]
    Units: subjects
        DBP ≤ 50 mmHg; ≥ 20 mmHG decrease
    4
        SBP ≤ 90 mmHg; ≥ 30 mmHg decrease
    1
        Pulse ≥ 100 bpm; ≥ 30 bpm increase
    1
        Temperature ≥ 1.1° C decrease
    19
        Temperature > 38.5° C or ≥ 1.1° C increase
    11
        Weight ≥ 7% decrease
    27
        Weight ≥ 7% increase
    25
    Notes
    [7] - subjects with post-baseline values for each parameter
    No statistical analyses for this end point

    Primary: Columbia-Suicide Severity Rating Scale (C-SSRS) Summary

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    End point title
    Columbia-Suicide Severity Rating Scale (C-SSRS) Summary [8]
    End point description
    The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. The C-SSRS was administered to the subject and an assessment completed using information gathered from the subject and caregiver. Summary data presents the number of subjects with suicidal ideation or behavior at any time during the study.
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation) plus 30 days follow-up
    Notes
    [8] - 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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    342
    Units: subjects
        Ideation: wish to be dead
    12
        Ideation: non-specific active suicidal thoughts
    3
        Ideation: active thoughts without intent to act
    2
        Ideation: active thoughts with some intent/no plan
    0
        Ideation: active thoughts with plan and intent
    0
        Behavior: actual attempt
    0
        Behavior: interrupted attempt
    0
        Behavior: aborted attempt
    0
        Behavior: preparatory acts or behavior
    0
        Behavior: suicidal behavior
    0
        Behavior: completed suicide
    0
        Subjects with suicidal ideations
    13
        Subjects with suicidal ideations only
    13
        Subjects with suicidal behaviors
    0
        Subjects with suicidal behaviors or ideations
    13
    No statistical analyses for this end point

    Primary: Mean Change from Baseline in Cornell Scale for Depression in Dementia (CSDD)

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    End point title
    Mean Change from Baseline in Cornell Scale for Depression in Dementia (CSDD) [9]
    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 two 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.
    End point type
    Primary
    End point timeframe
    Baseline (Day -1), Final Evaluation (up to Week 28)
    Notes
    [9] - 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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    208 [10]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.26 ± 2.36
    Notes
    [10] - subjects with baseline and post-baseline values
    No statistical analyses for this end point

    Primary: Number of Subjects Meeting Criteria for Potentially Clinically Significant Electrocardiogram Values

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    End point title
    Number of Subjects Meeting Criteria for Potentially Clinically Significant Electrocardiogram Values [11]
    End point description
    Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals.
    End point type
    Primary
    End point timeframe
    Day -1 through Week 28 (or premature discontinuation).
    Notes
    [11] - 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: Safety data was summarized using descriptive statistics. No statistical testing was performed.
    End point values
    ABT-126
    Number of subjects analysed
    341 [12]
    Units: subjects
        Bazett QTC interval > 500 msec
    5
        Bazett QTC interval > 60 msec increase
    7
        Fredericia QTC interval > 500 msec
    2
        Fredericia QTC interval > 60 msec increase
    5
    Notes
    [12] - subjects with post-baseline values for the respective parameter
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day -1 through Week 28 (or premature discontinuation) of treatment plus 30 days. Mean (SD) number of treatment exposure days was 163.4 (± 45.37).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    ABT-126
    Reporting group description
    ABT-126 25 mg hard gelatin capsule administered orally beginning at 75 mg once daily (QD), which could have been adjusted downward in 25 mg increments with the permission of the AbbVie medical monitor for safety or tolerability issues.

    Serious adverse events
    ABT-126
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 342 (8.77%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gait disturbance
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Delerium
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal lesion
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Urinary retention
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 342 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ABT-126
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 342 (21.05%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    23 / 342 (6.73%)
         occurrences all number
    26
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    20 / 342 (5.85%)
         occurrences all number
    21
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    19 / 342 (5.56%)
         occurrences all number
    22
    Diarrhoea
         subjects affected / exposed
    13 / 342 (3.80%)
         occurrences all number
    14
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    14 / 342 (4.09%)
         occurrences all number
    18

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2013
    The purpose of this amendment is to: ● Add additional contact information to Title Page, Section 6.5, and Section 7.0 for AbbVie medical monitor. ● Add rating scales to assess apathy symptoms associated with Alzheimer's disease (AD) measured by Dementia in Apathy Interview and Rating (DAIR) and the Apathy Evaluation Scale (AES). ● Add rating scales to assess impairment of executive function associated with Alzheimer's disease measured by change in behavioral symptoms (Everyday Cognition [eCOG], Frontal Systems Behavior Scale [FrSBe]), as well cognitive performance tests (such as Controlled Oral Word Association Test [COWAT], Categorical Verbal Fluency Test [CFT], Trails Making Test A [TMT-A] and Trails Making Test B [TMT-B], Digit Symbol Substitution Test [DSST], Letter Number Sequencing [LNS], Spatial Span [SS] Test, and Digit Span Backward [DSB]). ● Update language in Section 5.3.1.1 (12-Lead ECG) regarding the timing of the ECGs relative to blood sample collection. Delete reference to blinded study drug assignment, in order to clarify that ECGs should be obtained prior to any blood collections, only if these procedures are scheduled within approximately 30 minutes of each other. ● Delete the 14 day follow-up visit from the text in Section 5.4.1, in order to ensure consistency within the protocol. ● Correction in Section 8.1.3.1 (Cumulative Data Set) regarding the baseline for those subjects who received ABT-126 in Study M11-793 and who had a gap of 7 days or less between studies. ● Other changes to the protocol were for administrative purposes, to correct typographical errors or ensure consistency throughout the protocol.

    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.
    This extension study was terminated on 15 January 2014 due to the insufficient efficacy of ABT-126 in the double-blind phase 2 study 2011-004849-40 (M11-793) to support further clinical development.
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