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    Clinical Trial Results:
    A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects in the Early (Predementia) Alzheimer’s Disease Spectrum

    Summary
    EudraCT number
    2014-002159-24
    Trial protocol
    BE   SE   ES   NL   DE  
    Global end of trial date
    11 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Dec 2017
    First version publication date
    06 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    54861911ALZ2002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02260674
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV (JCI)
    Sponsor organisation address
    Turnhoutseweg 30, B2340 Beerse, Belgium,
    Public contact
    Janssen-Cilag International NV, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen-Cilag International NV, Clinical Registry Group, ClinicalTrialsEU@its.jnj.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
    11 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to investigate the longer-term safety and tolerability of JNJ-54861911 during 6 months of treatment in subjects in the early (predementia) Alzheimer’s Disease (AD) spectrum.
    Protection of trial subjects
    The safety assessments included monitoring of adverse events (AEs), changes in clinical laboratory test values (hematology, serum chemistry, alpha 1-acid glycoprotein, coagulation, urinalysis and hormones), vital sign measurements, physical and neurological examination results, ophthalmologic examinations, dermatological examinations and Electrocardiogram (ECG) at defined timepoints from screening phase through study completion.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Feb 2016
    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
    Belgium: 15
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Spain: 46
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Sweden: 14
    Worldwide total number of subjects
    114
    EEA total number of subjects
    114
    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)
    25
    From 65 to 84 years
    89
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 12 February 2016 to 11 June 2016 at 21 sites in 6 countries.

    Pre-assignment
    Screening details
    A total of 114 subjects were enrolled in this study, including 27 subjects who participated previously in study 54861911ALZ1005 (roll-over subjects). Subjects who did not previously participate were randomly assigned to 1 of the 3 treatment groups and subjects who previously participated were continued on the same blinded treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo as 2 oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 1 oral tablet once daily up to Month 6 to match JNJ-54861911 5 or 25 milligrams per day (mg/day) dose groups.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo as 1 or 2 oral tablets once daily matching to dose of assigned dose groups.

    Arm title
    JNJ-54861911 10 mg
    Arm description
    Subjects received JNJ-54861911 10 mg as (2*5 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 5 mg (1 tablet) once daily up to Month 6.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-54861911
    Investigational medicinal product code
    Other name
    JNJ-54861911-AAA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-54861911 10 mg as (2*5 mg) oral tablets once daily.

    Arm title
    JNJ-54861911 50 mg
    Arm description
    Subjects received JNJ-54861911 50 mg as (2*25 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 25 mg (1 tablet) once daily up to Month 6.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-54861911
    Investigational medicinal product code
    Other name
    JNJ-54861911-AAA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-54861911 50 mg as (2*25 mg) oral tablets once daily.

    Number of subjects in period 1
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg
    Started
    39
    37
    38
    Completed
    37
    34
    28
    Not completed
    2
    3
    10
         Noncompliance with study drug
    -
    -
    1
         Physician decision
    1
    -
    1
         Adverse event, serious fatal
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    6
         Consent withdrawn by subject
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 1 oral tablet once daily up to Month 6 to match JNJ-54861911 5 or 25 milligrams per day (mg/day) dose groups.

    Reporting group title
    JNJ-54861911 10 mg
    Reporting group description
    Subjects received JNJ-54861911 10 mg as (2*5 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 5 mg (1 tablet) once daily up to Month 6.

    Reporting group title
    JNJ-54861911 50 mg
    Reporting group description
    Subjects received JNJ-54861911 50 mg as (2*25 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 25 mg (1 tablet) once daily up to Month 6.

    Reporting group values
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg Total
    Number of subjects
    39 37 38 114
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    7 6 12 25
        From 65 to 84 years
    32 31 26 89
        85 years and over
    0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    70.3 ± 5.38 70.9 ± 6.58 68.1 ± 8.55 -
    Title for Gender
    Units: subjects
        Female
    23 19 18 60
        Male
    16 18 20 54

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 1 oral tablet once daily up to Month 6 to match JNJ-54861911 5 or 25 milligrams per day (mg/day) dose groups.

    Reporting group title
    JNJ-54861911 10 mg
    Reporting group description
    Subjects received JNJ-54861911 10 mg as (2*5 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 5 mg (1 tablet) once daily up to Month 6.

    Reporting group title
    JNJ-54861911 50 mg
    Reporting group description
    Subjects received JNJ-54861911 50 mg as (2*25 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 25 mg (1 tablet) once daily up to Month 6.

    Primary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    An Adverse Event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to Month 6 that were absent before treatment or that worsened relative to pretreatment state. subjects who were randomized, received at least 1 dose of double-blind study drug, and contributed safety data after the start of study treatment.
    End point type
    Primary
    End point timeframe
    up to 6 months (Treatment Period)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was performed and no inferential statistical analyses was performed for this endpoint.
    End point values
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    39
    37
    38
    Units: Subjects
    27
    23
    31
    No statistical analyses for this end point

    Secondary: Plasma Concentration of JNJ-54861911

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    End point title
    Plasma Concentration of JNJ-54861911 [2]
    End point description
    Plasma concentration of JNJ- 54861911 were assessed. Here, 'Number of subjects analysed' represents the number of subjects evaluable for this outcome measure and 'n' represents the number of subjects evaluable for the specific category. PK populations included all subjects who were evaluable for PK analysis.
    End point type
    Secondary
    End point timeframe
    Days 28, 56, 84, 112, 140 and 168
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specified arms only.
    End point values
    JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    36
    38
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 28 (n = 36,38)
    38.39 ± 36.532
    214.38 ± 238.259
        Day 56 (n = 36,36)
    31.76 ± 21.745
    179.05 ± 182.705
        Day 84 (n = 35,32)
    25.90 ± 13.838
    175.20 ± 159.107
        Day 112 (n = 35,30)
    25.53 ± 15.513
    124.57 ± 102.414
        Day 140 (n = 32,30)
    22.01 ± 11.031
    114.00 ± 85.782
        Day 168 (n = 34,28)
    19.65 ± 11.355
    114.94 ± 96.962
    No statistical analyses for this end point

    Secondary: Cerebrospinal Fluid (CSF) Concentration of JNJ-54861911

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    End point title
    Cerebrospinal Fluid (CSF) Concentration of JNJ-54861911 [3]
    End point description
    Cerebrospinal Fluid (CSF) concentration of JNJ-54861911 were assessed. Here, 'Number of subjects analysed' represents the number of subjects evaluable for this outcome measure. PK populations included all subjects who were evaluable for PK analysis.
    End point type
    Secondary
    End point timeframe
    Day 168
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was planned to be reported for the specified arms only.
    End point values
    JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    30
    22
    Units: ng/mL
        arithmetic mean (standard deviation)
    1.88 ± 1.156
    10.50 ± 8.124
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in CSF Amyloid-Beta (A-Beta) Fragments at Day 168

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    End point title
    Percent Change From Baseline in CSF Amyloid-Beta (A-Beta) Fragments at Day 168
    End point description
    Percent change from baseline in CSF A-beta species (A beta 1-37, A beta 1-38, A beta 1-40 and A beta 1-42) were summarized. subjects who were randomized, received at least 1 dose of double-blind study drug, and contributed safety data after the start of study treatment. Here 'n' represents the number of subjects evaluable for specific category.
    End point type
    Secondary
    End point timeframe
    Day 168
    End point values
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    39 [4]
    37 [5]
    38 [6]
    Units: percent change
    arithmetic mean (standard deviation)
        Amyloid Beta 1-37 (n = 27,30)
    -1.37 ± 14.558
    -47.09 ± 19.240
    -81.41 ± 11.400
        Amyloid Beta 1-38 (n = 27,29)
    0.19 ± 14.345
    -44.92 ± 18.574
    -80.07 ± 12.239
        Amyloid Beta 1-40 (n = 27,30)
    -1.48 ± 15.972
    -48.93 ± 15.608
    -82.28 ± 10.087
        Amyloid Beta 1-42 (n = 27,30)
    -5.94 ± 18.985
    -43.94 ± 16.894
    -76.86 ± 10.546
    Notes
    [4] - Safety analysis population
    [5] - Safety analysis population
    [6] - Safety analysis population
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in CSF Soluble Amyloid Precursor Protein (sAPP) Fragments at Day 168

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    End point title
    Percent Change From Baseline in CSF Soluble Amyloid Precursor Protein (sAPP) Fragments at Day 168
    End point description
    Percent change from baseline in CSF sAPP (sAPP alpha, sAPP beta) fragments were summarized. subjects who were randomized, received at least 1 dose of double-blind study drug, and contributed safety data after the start of study treatment. Here 'n' represents the number of subjects evaluable for specific category.
    End point type
    Secondary
    End point timeframe
    Day 168
    End point values
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    39 [7]
    37 [8]
    38 [9]
    Units: percent change
    arithmetic mean (standard deviation)
        sAPPα (n = 27,30)
    -3.30 ± 14.642
    61.76 ± 19.489
    115.35 ± 43.132
        sAPPβ (n = 27,30)
    -3.34 ± 15.005
    -49.76 ± 15.941
    -81.00 ± 11.440
    Notes
    [7] - Safety analysis population
    [8] - Safety analysis population
    [9] - Safety analysis population
    No statistical analyses for this end point

    Secondary: Plasma Amyloid-Beta Fragment (1-40) Levels at Baseline and day 168

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    End point title
    Plasma Amyloid-Beta Fragment (1-40) Levels at Baseline and day 168
    End point description
    Plasma A beta (1-40) levels were summarized. Subjects who were randomized, received at least 1 dose of double-blind study drug, and contributed safety data after the start of study treatment. Here 'N' represents the number of subjects evaluable for specific outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 168
    End point values
    Placebo JNJ-54861911 10 mg JNJ-54861911 50 mg
    Number of subjects analysed
    35
    34
    28
    Units: nanogram per liter (ng/L)
    arithmetic mean (standard deviation)
        Baseline
    165.98 ± 49.744
    162.88 ± 60.785
    172.18 ± 41.431
        Day 168
    170.33 ± 34.141
    56.43 ± 20.604
    24.56 ± 9.344
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to follow-up (approximately 10 months)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 1 oral tablet once daily up to Month 6 to match JNJ-54861911 5 or 25 milligrams per day (mg/day) dose groups.

    Reporting group title
    JNJ-54861911 50 mg
    Reporting group description
    Subjects received JNJ-54861911 50 mg as (2*25 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 25 mg (1 tablet) once daily up to Month 6.

    Reporting group title
    JNJ-54861911 10 mg
    Reporting group description
    Subjects received JNJ-54861911 10 mg as (2*5 mg) oral tablets once daily for at least 2 months. After amendment 4, the dose was lowered to 5 mg (1 tablet) once daily up to Month 6.

    Serious adverse events
    Placebo JNJ-54861911 50 mg JNJ-54861911 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 39 (10.26%)
    8 / 38 (21.05%)
    2 / 37 (5.41%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Temporal Arteritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Head Injury
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Joint Dislocation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Investigations
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Transaminases Increased
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Squamous Cell Carcinoma of Head and Neck
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         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 Tamponade
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Renal and urinary disorders
    Bladder Neck Sclerosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Haematuria
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Cholelithiasis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Skin and subcutaneous tissue disorders
    Toxic Skin Eruption
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (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
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 37 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo JNJ-54861911 50 mg JNJ-54861911 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 39 (48.72%)
    24 / 38 (63.16%)
    15 / 37 (40.54%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    3
    1
    2
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    0
    Psychiatric disorders
    Mood Altered
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    1
    Injury, poisoning and procedural complications
    Procedural Pain
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
    0 / 37 (0.00%)
         occurrences all number
    1
    3
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    Transaminases Increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    0
    1
    2
    Vitamin B12 Decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 38 (7.89%)
    2 / 37 (5.41%)
         occurrences all number
    0
    3
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    2
    Headache
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    6
    2
    3
    Syncope
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    1
    2
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    7 / 38 (18.42%)
    3 / 37 (8.11%)
         occurrences all number
    3
    7
    4
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    0
    Skin and subcutaneous tissue disorders
    Actinic Keratosis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    0
    Eczema
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
    0 / 37 (0.00%)
         occurrences all number
    1
    4
    0
    Pruritus
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    2
    Urticaria
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    3
    2
    2
    Tendonitis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    1
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 39 (12.82%)
    3 / 38 (7.89%)
    3 / 37 (8.11%)
         occurrences all number
    5
    3
    3
    Urinary Tract Infection
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    4
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2015
    Amendment included the following changes: Clarification on the ophthalmologic and Optical Coherence Tomography (OCT) examinations described; Statement describing the audiotaping and central review of the Clinical Dementia Rating Scale (CDR); The replacement of multiple Ribonucleic Acid (RNA) samples during treatment by a single plasma pharmacodynamic (PD) sample during screening in order to correlate the screening Cerebrospinal Fluid (CSF) biomarker profile with the plasma profile; Implementation of comments/remarks received by the different Health Authorities and Ethics Committees during the initial review of the protocol; Adjustment of the Electrocardiogram (ECG) collections to triplicate recordings at all time points and a shift from pre dose to post dose assessments post Day 1 based on the preliminary outcome of the tQT study (54861911ALZ1007); Update in concomitant medication based on in vitro transporter Drug-Drug Interaction (DDI) studies as well as preliminary data of the clinical DDI studies performed; For subjects rolling over from study 54861911ALZ1005: a new baseline Magnetic Resonance Imaging (MRI) scan might have been required (not for eligibility but for on treatment comparisons) in case changes occurred between studies to the technical set up of the MRI for example (e.g.), change of scanner; Inclusion of roll over subjects from study 54861911ALZ1005, aged 60 to 64 years inclusive, who were asymptomatic at risk for Alzheimer’s dementia were allowed.
    06 Mar 2015
    Amendment included changes to allow the use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors based on the read out of 2 clinical DDI studies (54861911ALZ1009 and 54861911ALZ1010) with an instruction to investigators to use these inhibitors with care. This update was implemented based on 2 clinical DDI studies (54861911ALZ1009 and 54861911ALZ1010), which evaluated the interaction potential of JNJ-54861911 when co-administered with CYP3A4 inhibitors.
    08 Feb 2016
    A data review committee (DRC) evaluated the safety data during the course of the study. Based upon the observation of a possible safety signal, instructions regarding a reduction in dosage (from 50 milligrams {mg} to 25 mg and from 10 mg to 5 mg), an increase in the frequency of safety monitoring (additional safety monitoring for liver function at Months 4 and 5), and additional guidance on rules of discontinuation of treatment were provided, implemented urgently with a note to file (28 January 2016), followed by the fourth amendment.

    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.
    As a result of an urgent safety measure, the doses of both active arms were reduced by 50 percent (%). Additionally, the groups with a reduction of the dose during study have variable duration of treatment for initial and lowered dose, respectively.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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