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    Clinical Trial Results:
    Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of idalopirdine (Lu AE58054) in patients with mild-moderate Alzheimer's disease treated with donepezil

    Summary
    EudraCT number
    		 2012-004763-45
    Trial protocol
    		 CZ   IT   BE   DE   DK   BG   ES  
    Global end of trial date
    19 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2017
    First version publication date
    04 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14861A STARSHINE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01955161
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9 Valby, Denmark, , Valby, Denmark, 2500
    Public contact
    lundbeckclinicaltrials@lundbeck.com, H. Lundbeck A/S, lundbeckclinicaltrials@lundbeck.com
    Scientific contact
    lundbeckclinicaltrials@lundbeck.com, H. Lundbeck A/S, lundbeckclinicaltrials@lundbeck.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
    19 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish efficacy of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-moderate Alzheimer’s disease
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
    Background therapy
    		 Donezepil
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2013
    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
    Poland: 73
    Country: Number of subjects enrolled
    Spain: 60
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Bulgaria: 60
    Country: Number of subjects enrolled
    Czech Republic: 109
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Germany: 59
    Country: Number of subjects enrolled
    Italy: 36
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    Argentina: 70
    Country: Number of subjects enrolled
    Chile: 90
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Ukraine: 61
    Country: Number of subjects enrolled
    United States: 130
    Country: Number of subjects enrolled
    South Africa: 57
    Worldwide total number of subjects
    933
    EEA total number of subjects
    485
    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)
    143
    From 65 to 84 years
    704
    85 years and over
    86

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo adjunct to 10 mg Donepezil Placebo: Once daily, matching placebo capsules, orally
    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
    Matching placebo capsules, once daily

    Arm title
    		 Idalopirdine 30 mg
    Arm description
    		 Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idalopirdine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Encapsulated tables 30 mg, once daily

    Arm title
    		 Idalopirdine 60 mg
    Arm description
    		 Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idaloprirdine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Encapsulated tablets 60 mg, once daily

    Number of subjects in period 1
    		Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Started
    310
    313
    310
    Completed
    283
    288
    275
    Not completed
    27
    25
    35
         Adverse event, serious fatal
    1
    1
    3
         Other reason: caregiver unavailable
    1
    -
    -
         Consent withdrawn by subject
    9
    8
    12
         Other reason: moved to nursing home
    -
    1
    -
         Other reason: physician decision
    -
    1
    1
         Adverse event, non-fatal
    10
    14
    15
         Other reason: insufficient compliance
    -
    -
    1
         Other reason: disallowed medication
    1
    -
    1
         Other reason: patient's will
    -
    -
    1
         Withdrawal before treatment
    2
    -
    1
         Other reason: primary biliary cirrhosis
    1
    -
    -
         Protocol deviation
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 933 933
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 143 143
        From 65-84 years
    		 704 704
        85 years and over
    		 86 86
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.8 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 608 608
        Male
    		 325 325
    Race
    Units: Subjects
        Asian
    		 5 5
        Native Hawaiian or Other Pacific Islander
    		 3 3
        Black or African American
    		 8 8
        White
    		 857 857
        Unknown or Not Reported
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo adjunct to 10 mg Donepezil Placebo: Once daily, matching placebo capsules, orally

    Reporting group title
    Idalopirdine 30 mg
    Reporting group description
    		 Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally

    Reporting group title
    Idalopirdine 60 mg
    Reporting group description
    		 Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally

    Primary: Change in cognition

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    End point title
    		 Change in cognition
    End point description
    Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    304
    310
    308
    Units: Unit on a scale
        least squares mean (standard error)
    0.13 ± 0.35
    0.47 ± 0.35
    0.18 ± 0.35
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 30 mg
    Statistical analysis description
    For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%
    Comparison groups
    Placebo v Idalopirdine 30 mg
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9591 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 1.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.47
    Notes
    [1] - Corrected for multiplicity
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 60 mg
    Statistical analysis description
    For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.
    Comparison groups
    Placebo v Idalopirdine 60 mg
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 0.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.47
    Notes
    [2] - Corrected for multiplicity according to the multiple testing procedure

    Secondary: Change in daily functioning

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    End point title
    		 Change in daily functioning
    End point description
    Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    304
    310
    308
    Units: Units on a scale
        least squares mean (standard error)
    -2.03 ± 0.49
    -2.12 ± 0.48
    -2.02 ± 0.49
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 30 mg
    Statistical analysis description
    For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.
    Comparison groups
    Placebo v Idalopirdine 30 mg
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 1.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66
    Notes
    [3] - Corrected for multiplicity according toe the multiple testing procedure
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 60 mg
    Comparison groups
    Placebo v Idalopirdine 60 mg
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 1 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 1.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66
    Notes
    [4] - For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.
    [5] - Corrected for multiplicity according to the multiple testing procedure

    Secondary: Change in global impression

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    End point title
    		 Change in global impression
    End point description
    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    303
    309
    307
    Units: Units on a scale
        least squares mean (standard error)
    4.29 ± 0.07
    4.32 ± 0.07
    4.13 ± 0.07
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 30 mg
    Statistical analysis description
    For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.
    Comparison groups
    Placebo v Idalopirdine 30 mg
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [6] - Corrected for multiplicity according to the multiple testing procedure
    Statistical analysis title
    		 Superiority: Placebo vs. idalopirdine 60 mg
    Statistical analysis description
    For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.
    Comparison groups
    Placebo v Idalopirdine 60 mg
    Number of subjects included in analysis
    610
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [7] - Corrected for multiplicity according to the multiple testing procedure

    Secondary: Change in behavioural disturbance

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    End point title
    		 Change in behavioural disturbance
    End point description
    Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score. The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]), severity (a 3-point scale from 1 [mild] to 3 [marked]), and caregiver distress (a 5-point scale from 0 [not at all] to 5 [very severely or extremely]). Total score of the frequency ratings multiplied by the severity ratings ranges from 0 to 144 and the total score of the caregiver distress ratings ranges from 0 to 60.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    304
    310
    308
    Units: Units on a scale
        least squares mean (standard error)
    -0.21 ± 0.62
    -0.21 ± 0.62
    -0.39 ± 0.63
    No statistical analyses for this end point

    Secondary: Change in individual behavioural disturbance items

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    End point title
    		 Change in individual behavioural disturbance items
    End point description
    Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]), severity (a 3-point scale from 1 [mild] to 3 [marked]), and caregiver distress (a 5-point scale from 0 [not at all] to 5 [very severely or extremely]). Total score of the frequency ratings multiplied by the severity ratings ranges from 0 to 144 and the total score of the caregiver distress ratings ranges from 0 to 60.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    304
    310
    308
    Units: Units on a scale
    least squares mean (standard error)
        Delusions
    -0.11 ± 0.09
    -0.04 ± 0.09
    -0.01 ± 0.09
        Hallucinations
    0.13 ± 0.07
    0.03 ± 0.07
    -0.03 ± 0.07
        Agitation/agression
    0.01 ± 0.11
    0.04 ± 0.11
    0.1 ± 0.11
        Depression/dysphoria
    0.02 ± 0.09
    -0.06 ± 0.09
    -0.08 ± 0.1
        Anxiety
    -0.02 ± 0.11
    -0.13 ± 0.11
    -0.13 ± 0.11
        Elation/euphoria
    0.09 ± 0.05
    0.03 ± 0.05
    0.03 ± 0.05
        Apathy/indifference
    -0.18 ± 0.15
    -0.23 ± 0.15
    -0.27 ± 0.15
        Disinhibition
    0.05 ± 0.08
    -0.06 ± 0.08
    -0.01 ± 0.08
        Irritability/lability
    -0.14 ± 0.12
    0.02 ± 0.12
    0 ± 0.12
        Aberrant mtor behaviour
    0.03 ± 0.12
    0.33 ± 0.12
    -0.13 ± 0.13
        Sleep
    0.03 ± 0.11
    0.01 ± 0.11
    0.03 ± 0.11
        Appetite/eating disorder
    -0.08 ± 0.13
    -0.14 ± 0.13
    -0.04 ± 0.13
    No statistical analyses for this end point

    Secondary: Change in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline

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    End point title
    		 Change in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline
    End point description
    The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items, where anxiety is one of the behavioural items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]), severity (a 3-point scale from 1 [mild] to 3 [marked]), and caregiver distress (a 5-point scale from 0 [not at all] to 5 [very severely or extremely]). Total score of the frequency ratings multiplied by the severity ratings ranges from 0 to 144 and the total score of the caregiver distress ratings ranges from 0 to 60.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    88
    83
    76
    Units: Units on a scale
        least squares mean (standard error)
    -1.12 ± 0.3
    -1.56 ± 0.3
    -1.64 ± 0.32
    No statistical analyses for this end point

    Secondary: Clinical improvement

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    End point title
    		 Clinical improvement
    End point description
    Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    284
    290
    278
    Units: Count of participants
    34
    37
    27
    No statistical analyses for this end point

    Secondary: Clinical worsening

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    End point title
    		 Clinical worsening
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    284
    290
    278
    Units: Count of participants
    40
    42
    33
    No statistical analyses for this end point

    Secondary: Change in cognitive aspects of mental function

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    End point title
    		 Change in cognitive aspects of mental function
    End point description
    Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    282
    288
    274
    Units: Units on a scale
        least squares mean (standard error)
    0.06 ± 0.16
    -0.27 ± 0.16
    0.27 ± 0.17
    No statistical analyses for this end point

    Secondary: Change in health-related quality of life (EQ-5D) utility score

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    End point title
    		 Change in health-related quality of life (EQ-5D) utility score
    End point description
    Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1).
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    301
    306
    304
    Units: Units on a scale
        least squares mean (standard error)
    -0.01 ± 0.01
    0 ± 0.01
    0 ± 0.01
    No statistical analyses for this end point

    Secondary: Change in health-related quality of life (EQ-5D VAS)

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    End point title
    		 Change in health-related quality of life (EQ-5D VAS)
    End point description
    Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo Idalopirdine 30 mg Idalopirdine 60 mg
    Number of subjects analysed
    301
    307
    304
    Units: Units on scale
        least squares mean (standard error)
    -0.4 ± 1.01
    -0.12 ± 1.01
    0.34 ± 1.03
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Idalopirdine 60 mg
    Reporting group description
    		 -

    Reporting group title
    Idalopirdine 30 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Idalopirdine 60 mg Idalopirdine 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 308 (3.90%)
    20 / 309 (6.47%)
    18 / 313 (5.75%)
         number of deaths (all causes)
    1
    3
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 308 (0.00%)
    2 / 309 (0.65%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Colostomy closure
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Rehabilitation therapy
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         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
    Sudden death
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed [1]
    0 / 198 (0.00%)
    1 / 201 (0.50%)
    0 / 208 (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
    Vaginal fistula
         subjects affected / exposed [2]
    1 / 198 (0.51%)
    0 / 201 (0.00%)
    0 / 208 (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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Dyspnoea
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 308 (0.32%)
    1 / 309 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Impulse-control disorder
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Bilirubin conjugated increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Blood bilirubin increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    C-reactive protein increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 308 (0.32%)
    1 / 309 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Radius fracture
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         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 myocardial infarction
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Bradycardia
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Nervous system disorders
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Cerebral haematoma
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
    Cerebral ischaemia
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dementia alzheimer's type
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Presyncope
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 308 (0.32%)
    1 / 309 (0.32%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Pancreatitis acute
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Calculus bladder
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         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
    Spinal pain
         subjects affected / exposed
    2 / 308 (0.65%)
    0 / 309 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (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
    Bacterial diarrhoea
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 308 (0.65%)
    0 / 309 (0.00%)
    0 / 313 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 308 (0.00%)
    1 / 309 (0.32%)
    0 / 313 (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 / 308 (0.00%)
    1 / 309 (0.32%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 308 (0.32%)
    0 / 309 (0.00%)
    1 / 313 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only relevant in woman
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only relevant in women
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Idalopirdine 60 mg Idalopirdine 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 308 (12.66%)
    49 / 309 (15.86%)
    56 / 313 (17.89%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 308 (0.32%)
    15 / 309 (4.85%)
    17 / 313 (5.43%)
         occurrences all number
    1
    15
    17
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    27 / 308 (8.77%)
    16 / 309 (5.18%)
    27 / 313 (8.63%)
         occurrences all number
    52
    41
    55
    Fall
         subjects affected / exposed
    15 / 308 (4.87%)
    19 / 309 (6.15%)
    16 / 313 (5.11%)
         occurrences all number
    16
    20
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2013
    PA01 Before study start The Drop-out Retrieval Visit was added. Analysis of primary and key secondary endpoints: exploratory MMRM analysis pooling the 30 and 60mg doses and testing the effect versus placebo was added. Sensitivity analyses of the primary and key secondary endpoints: MMRM analyses of efficacy data collected at the Withdrawal Follow-up Visit and the Drop-out Retrieval Visit for withdrawn patients were added. A secondary endpoint addressing the secondary objective was added: change from baseline to Week 24 in NPI Anxiety score in patients with an NPI Anxiety score ≥2 at baseline. Analysis of secondary endpoints: changes from baseline in NPI Anxiety score at Weeks 4, 12, and 24 in patients with a score ≥2 at baseline analysed using the same methodology as that described for the primary endpoint were added. The ADAS-cog component of the clinical response definition at Week 24 was redefined from ADAS-cog change <-4 to ADAS-cog change ≤-4 (this change was repeated in PA02). Unblinding procedure: the investigator could break the code immediately if he/she judged it necessary to ensure the safety of the patient, without prior contact to the CRA, was added.
    19 Feb 2014
    PA02 After study start The Dependence Scale was added. Exclusion criterion 17: that patients with pacemakers were eligible provided they followed a routine check-up with their doctor and were considered stable was clarified. Exclusion criterion 28: the exclusion criteria for heart rate and the duration of the PR interval were revised. The possibility of re-screening patients who failed screening due to certain treatable medical conditions but who were otherwise eligible was added. Concomitant medication use was clarified.

    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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