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    Summary
    EudraCT Number:2015-000948-42
    Sponsor's Protocol Code Number:54861911ALZ2003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-10-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000948-42
    A.3Full title of the trial
    A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel
    Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-
    54861911 in Subjects who are Asymptomatic At Risk for Developing
    Alzheimer's Dementia
    Studio multicentrico di Fase 2b/3 randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di JNJ-54861911 in soggetti asintomatici e a rischio di sviluppare la demenza di Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Trial of JNJ-54861911 in Participants who are
    Asymptomatic At Risk for Developing Alzheimer's Dementia
    Studio su sicurezza ed efficacia di JNJ-54861911 in soggetti che sono asintomatici e a rischio di sviluppare la malattia di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    not available
    non disponibile
    A.4.1Sponsor's protocol code number54861911ALZ2003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Pharmaceutica N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031 071 524 2166
    B.5.5Fax number0031 071 524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-54861911
    D.3.2Product code JNJ-54861911
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1200493-78-2
    D.3.9.2Current sponsor codeJNJ-54861911
    D.3.9.3Other descriptive nameJNJ-54861911-AAA
    D.3.9.4EV Substance CodeSUB107735
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-54861911
    D.3.2Product code JNJ-54861911
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1200493-78-2
    D.3.9.2Current sponsor codeJNJ-54861911
    D.3.9.3Other descriptive nameJNJ-54861911-AAA
    D.3.9.4EV Substance CodeSUB107735
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease (AD) is a neurodegenerative disease associated with aging. AD patients suffer from cognition deficits and memory loss as well
    as behavioral problems such as anxiety.
    La malattia di Alzheimer è una malattia neurodegenerativa associata all'età.Pazienti con questa malattia soffrono di deficit cognitivi e perdita di memoria,oltre a problemi comportamentali come ansia.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this trial is to assess the efficacy and safety of JNJ-
    54861911 compared with placebo in the treatment of participants who
    are Asymptomatic At Risk for Development Alzheimer's Disease, also
    known as pre-clinical Alzheimer's Disease (AD).
    L’obiettivo primario di questo studio è quello di valutare l'efficacia e la sicurezza del trattamento con JNJ-54861911 rispetto al trattamento con placebo, in soggetti asintomatici e a rischio di sviluppare la demenza di Alzheimer (pre-clinica malattia di Alzheimer)
    E.2.2Secondary objectives of the trial
    To determine if JNJ-54861911 will slow the decline of cognitive function
    and performance of everyday activities, compared with placebo, based
    on the Cognitive Function Index (CFI).
    • Stabilire se JNJ-54861911 rallenti il declino della funzione cognitiva e delle prestazioni in relazione alle attività quotidiane, rispetto al placebo, in base all’indice di funzionalità cognitiva (Cognitive Function Index, CFI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be a man or woman 60 to 85 years of age, inclusive, at time of informed consent. Subjects 60 to 64 years of age must also have
    1 of the following 3 conditions:
    a. A positive family history for dementia (minimum of 1 first degree relative)
    b. A previously known APOE ɛ4 genotype
    c. A previously known biomarker status demonstrating elevated amyloid
    accumulation in CSF or PET
    2. Subjects must have a global CDR score of 0 at screening.
    3. Subjects must be able to read and write and must have adequate
    hearing and visual acuity to complete the psychometric tests. The legally
    acceptable representative must also be able to read and write.
    4. Subjects must have evidence of elevated amyloid accumulation by
    means of either:
    a. Low CSF Aβ1-42 levels at screening
    b. A positive amyloid PET scan at screening (depending on the site's PET
    capability)
    Note: The cut off value for CSF Aβ1-42 will be based on the value established by the central CSF screening laboratory and specified in a separate laboratory manual. Screening amyloid PET scans will be assessed centrally by a qualified reader for inclusion based on predefined criteria as documented in the imaging manual.
    1. soggetti maschi o femmine, di età compresa tra 60 e 85 anni inclusi alla firma del consenso. Soggetti di età compresa tra 60 e 64 anni devono inoltre avere 1 delle seguenti 3 condizioni:
    a. storia familiare clinica di demenza (minimo di parente di primo grado)
    b. genotipo APOE ɛ4 precedentemente conosciuto
    c. Biomarker status precedentemente conosciuto che dimostra un elevato accumulo di amiloide attraverso CSF o PET.
    2. soggetti devono avere un punteggio globale CDR di 0 allo screening
    3. soggetti devono essere in grado di leggere e scrivere e devono avere un udito adeguato e prontezza visuale per completare i test psicometrici. Il legale rappresentante inoltre deve essere in grado di leggere e scrivere.
    4. soggetti devono avere evidenza di un elevato accumulo di amiloide attraverso:
    a. bassi livelli di CSF Aβ1-42 allo screening
    b. immagine PET dell'amiloide positiva allo screening.
    E.4Principal exclusion criteria
    1. Subject is receiving an acetylcholinesterase (AChE) inhibitor and/or
    memantine at any time during screening or Day 1 predose.
    2. Subject has evidence of any brain disease other than potential very
    early signs of AD (eg, mild hippocampal atrophy) or typical age-related
    changes (eg, mild white matter hyperintensity on MRI). The screening
    MRI scan shall be interpreted by a local radiologist and a central
    radiologist for exclusionary findings prior to enrolling the subject. Both
    local and central interpretations shall be reviewed by the investigator; in
    case of disagreement, the central radiology report will be used to
    determine subject eligibility in consultation with the sponsor's medical
    monitor.
    3. Subject has any other abnormality that could cause a possible
    cognitive deficit (including, but not limited to vascular encephalopathy
    or large strokes [as imaged by cerebral MRI]).
    4. Subject has any contraindications for MRI (eg, prostheses, implants,
    claustrophobia, pacemaker)
    5. Subject has met criteria for dementia or has a brain disorder that can
    cause dementia.
    6. Subject has evidence of familial autosomal dominant AD (mutation
    identified in the family and/or subject prior to randomization).
    7. Subject has a history of or current thyroid disease or thyroid
    dysfunction, which is currently uncontrolled, unevaluated, or untreated.
    Subjects treated for thyroid disease may be enrolled following review of
    their diagnostic and treatment history records by the investigator and
    with written concurrence by the sponsor's medical monitor to ensure
    disease/treatment stability and compliance.
    8. Subject has a vitamin B12 or folic acid deficiency. A low vitamin B12
    level is exclusionary unless follow-up labs (homocysteine and
    methylmalonic acid) indicate that the value is not physiologically
    significant. Subjects treated with vitamin B12 or folic acid may be
    enrolled following review of their diagnostic and treatment history
    records by the investigator and with written concurrence by the
    sponsor's medical monitor to ensure disease/treatment stability and
    compliance.
    9. Subject has chromosome 21 trisomy (Down syndrome).
    10. Subject has a history within the past 2 years or current diagnosis of
    significant psychiatric illness, per the most current version of the
    Diagnostic and Statistical Manual of Mental Disorders (DSM) (including
    but not limited to major depressive disorders and anxiety disorders)
    (subjects who are symptom free or with minimal limited symptoms may
    be included); or the subject has a current diagnosis or history of
    schizophrenia or bipolar disorder.
    I criteri di esclusione principali comprendono il trattamento con inibitori dell’acetilcolinesterasi o con memantina durante lo screening o la pre-dose al Giorno 1; l’evidenza di malattia cerebrale diversa dai potenziali segni molto precoci di AD o dai cambiamenti tipici legati all’età; altre anomalie che causano possibili difetti cognitivi; un intervallo QT corretto per il battito cardiaco usando la formula di Fridericia (QTcF) di >450 msec; demenza o malattia cerebrale che può causare la demenza; e AD familiare autosomica dominante nota.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in the ADCS-PACC score from baseline.
    L’endpoint primario di efficacia è la variazione del punteggio ADCS-PACC dal basale al Mese 54.
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 months
    54 mesi
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the change from baseline in the CFI total score.
    Il principale endpoint secondario di efficacia è costituito dal cambiamento dal basale nel punteggio totale di CFI al Mese 54.
    E.5.2.1Timepoint(s) of evaluation of this end point
    54 months
    54 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Denmark
    Finland
    Germany
    Italy
    Japan
    Mexico
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 631
    F.4.2.2In the whole clinical trial 1654
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment
    Normale trattamento atteso
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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