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    Clinical Trial Results:
    Randomised, double-blind, parallel-group, placebo-controlled study of Lu AE58054 in patients with mild-moderate Alzheimer’s disease treated with an acetylcholinesterase inhibitor; Study 3

    Summary
    EudraCT number
    		 2012-004765-40
    Trial protocol
    		 CZ   GB   DE   SK   ES  
    Global end of trial date
    12 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jan 2018
    First version publication date
    28 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14863A STARBRIGHT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02006654
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, 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
    12 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer’s disease (AD)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
    Background therapy
    		 The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient’s individual maintenance dose, or galantamine at the patient’s individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2014
    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
    Australia: 42
    Country: Number of subjects enrolled
    Brazil: 45
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Israel: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 39
    Country: Number of subjects enrolled
    Mexico: 48
    Country: Number of subjects enrolled
    Singapore: 32
    Country: Number of subjects enrolled
    Serbia: 21
    Country: Number of subjects enrolled
    Turkey: 32
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    Slovakia: 56
    Country: Number of subjects enrolled
    Spain: 127
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Czech Republic: 79
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 80
    Worldwide total number of subjects
    734
    EEA total number of subjects
    373
    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)
    110
    From 65 to 84 years
    566
    85 years and over
    58

    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 Comparator: Placebo
    Arm description
    		 Placebo adjunct to base treatment with an AChEI
    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
    Once daily, matching placebo capsules, orally

    Arm title
    		 Experimental: Idalopirdine 60 mg (or 30 mg)
    Arm description
    		 Idalopirdine adjunct to base treatment with an AChEI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idalopirdine 60 mg (or 30 mg)
    Investigational medicinal product code
    Lu AE58054
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily, encapsulated tablets, orally

    Number of subjects in period 1
    		Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Started
    369
    365
    Completed
    324
    321
    Not completed
    45
    44
         Adverse event, serious fatal
    1
    -
         Insufficient compliance
    1
    -
         patient's will
    2
    1
         Withdrawal before treatment
    4
    2
         Mood disorder
    -
    1
         faecal incontinence
    -
    1
         Consent withdrawn by subject
    14
    12
         Adverse event, non-fatal
    16
    17
         Moving out of state
    -
    1
         Worsening cognitive condition
    -
    1
         disallowed medication
    1
    -
         Lost to follow-up
    1
    -
         Protocol deviation
    5
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 734 734
    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)
    		 110 110
        From 65-84 years
    		 566 566
        85 years and over
    		 58 58
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.9 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    		 464 464
        Male
    		 270 270
    Race
    Units: Subjects
        Asian
    		 79 79
        Black or African American
    		 19 19
        White
    		 594 594
        Unknown or Not Reported
    		 42 42

    End points

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    End points reporting groups
    Reporting group title
    Placebo Comparator: Placebo
    Reporting group description
    		 Placebo adjunct to base treatment with an AChEI

    Reporting group title
    Experimental: Idalopirdine 60 mg (or 30 mg)
    Reporting group description
    		 Idalopirdine adjunct to base treatment with an AChEI

    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 and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    356
    361
    Units: Units on a scale
        least squares mean (standard error)
    0.68 ± 0.37
    0.13 ± 0.38
    Statistical analysis title
    		 Change in Cognition
    Statistical analysis description
    For demonstrating efficacy, 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 idalopirdine at significance level 5%.
    Comparison groups
    Placebo Comparator: Placebo v Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2365 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46
    Notes
    [1] - Corrected for multiplicity

    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 change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    353
    357
    Units: Units on a scale
        least squares mean (standard error)
    4.32 ± 0.07
    4.39 ± 0.07
    Statistical analysis title
    		 Change in Global Impression
    Statistical analysis description
    For demonstrating efficacy, 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 at significance level 5%.
    Comparison groups
    Placebo Comparator: Placebo v Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4064 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    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 and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    356
    361
    Units: Units on a Scale
        least squares mean (standard error)
    -1.72 ± 0.50
    -1.05 ± 0.51
    Statistical analysis title
    		 Change in Daily Functioning
    Statistical analysis description
    For demonstrating efficacy, 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 at significance level 5%.
    Comparison groups
    Placebo Comparator: Placebo v Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4064 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 1.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63
    Notes
    [3] - 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]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    356
    361
    Units: Units on a scale
        least squares mean (standard error)
    -0.46 ± 0.53
    -0.74 ± 0.54
    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]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    356
    361
    Units: Units on a scale
    least squares mean (standard error)
        Delusions
    -0.00 ± 0.10
    0.03 ± 0.10
        Hallucinations
    0.05 ± 0.06
    0.08 ± 0.06
        Agitation/aggression
    0.15 ± 0.11
    0.03 ± 0.11
        Depression/dysphoria
    -0.28 ± 0.09
    -0.18 ± 0.09
        Anxiety
    -0.16 ± 0.09
    -0.07 ± 0.09
        Elation/euphoria
    0.02 ± 0.04
    0.03 ± 0.04
        Apathy/indifference
    -0.06 ± 0.15
    -0.19 ± 0.15
        Disinhibition
    0.12 ± 0.08
    -0.00 ± 0.08
        Irritability/lability
    0.10 ± 0.12
    -0.04 ± 0.12
        Aberrant motor behaviour
    0.08 ± 0.11
    0.11 ± 0.11
        Sleep
    -0.13 ± 0.11
    -0.12 ± 0.11
        Appetite/eating disorder
    -0.25 ± 0.12
    -0.21 ± 0.12
    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
    Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline 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]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    86
    83
    Units: Units on a scale
        least squares mean (standard error)
    -1.93 ± 0.32
    -1.52 ± 0.33
    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 Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    324
    321
    Units: Participants
    32
    35
    No statistical analyses for this end point

    Secondary: Clinical Worsening

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    End point title
    		 Clinical Worsening
    End point description
    Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    324
    321
    Units: Participants
    37
    40
    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 and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    323
    320
    Units: Units on a scale
        least squares mean (standard error)
    -0.64 ± 0.20
    -0.35 ± 0.20
    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). A higher EQ-5D score indicates a worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    351
    354
    Units: Units on a scale
        least squares mean (standard error)
    -0.01 ± 0.01
    -0.00 ± 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 and Week 24
    End point values
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Number of subjects analysed
    351
    353
    Units: Units on a scale
        least squares mean (standard error)
    -0.40 ± 1.00
    0.51 ± 1.02
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo Comparator: Placebo
    Reporting group description
    		 Placebo adjunct to base treatment with an AChEI

    Reporting group title
    Experimental: Idalopirdine 60 mg (or 30 mg)
    Reporting group description
    		 Idalopirdine adjunct to base treatment with an AChEI

    Serious adverse events
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 365 (6.03%)
    28 / 363 (7.71%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed [1]
    0 / 234 (0.00%)
    1 / 228 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 365 (0.55%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Behavioural and psychiatric symptoms of dementia
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality disorder
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram st segment depression
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 365 (0.27%)
    5 / 363 (1.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    2 / 365 (0.55%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 363 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 363 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 365 (0.55%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 363 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 363 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    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: This Adverse Event is only applicable for female subjects.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Comparator: Placebo Experimental: Idalopirdine 60 mg (or 30 mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 365 (17.53%)
    82 / 363 (22.59%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 365 (0.82%)
    19 / 363 (5.23%)
         occurrences all number
    3
    19
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 365 (0.55%)
    22 / 363 (6.06%)
         occurrences all number
    2
    22
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    43 / 365 (11.78%)
    40 / 363 (11.02%)
         occurrences all number
    71
    73
    Fall
         subjects affected / exposed
    21 / 365 (5.75%)
    19 / 363 (5.23%)
         occurrences all number
    21
    19

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2014
    PA01: Deletion of text regarding open-label extension study as it was no longer applicable for the study. 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. Clarification and specifications to the use of concomitant medication.
    02 Feb 2016
    PA02: The restriction regarding the number of patients to be included in each of the two base treatment strata was removed.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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