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    Summary
    EudraCT Number:2015-000948-42
    Sponsor's Protocol Code Number:54861911ALZ2003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 ConcernedSpain - AEMPS
    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
    Estudio de fase IIb/III, multicéntrico, aleatorizado, con doble ciego, controlado con placebo y de grupos paralelos para investigar la eficacia y la seguridad de JNJ-54861911 en sujetos asintomáticos con riesgo de desarrollar demencia de 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
    Eficacia y la seguridad de JNJ-54861911 en sujetos asintomáticos con riesgo de desarrollar demencia de Alzheimer
    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 N.V.
    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 number31071524 2166
    B.5.5Fax number31071524 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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Enfermedad de 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 enfermedad de Alzheimer (EA) es una enfermedad neurodegenerativa relacionada con el envejecimiento. Los pacientes sufren deficiencias cognitivas, pérdida de memoria y problemas de comportamiento.
    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 18.0
    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).
    La finalidad de este ensayo es evaluar la eficacia y seguridad de JNJ-54861911 frente al placebo en el tratamiento de participantes asintomáticos en riesgo de contraer la enfermedad de Alzheimer, también conocida como enfermedad de Alzheimer (AE) preclínica.
    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).
    Determinar si JNJ-54861911 ralentiza el descenso de las funciones cognitivas y el desempeño de las actividades cotidianas, en comparación con el placebo, según el Índice de Función Cognitiva (IFC).
    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 ?4 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 A?1-42 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 A?1-42 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. El sujeto deberá ser un hombre o una mujer entre 60 y 85 años de edad en el momento de la firma del consentimiento informado. Los sujetos entre 60 y 64 años también deberán contar con una de las tres condiciones siguientes:
    a. Antecedentes familiares de demencia (al menos 1 familiar de primer grado)
    b. Genotipo ApoE-?4 previamente conocido
    c. Estado de un biomarcador previamente conocido que demuestre una acumulación elevada de amiloides en el LCR o TEP
    2. Los sujetos deben tener una puntuación global de calmodulina de 0 durante la selección.
    3. Los sujetos deben ser capaces de leer y escribir y poseer una audición y agudeza visual adecuadas para completar las pruebas psicométricas. El representante legal también debe ser capaz de leer y escribir.
    4. Los sujetos deben haber dado muestras de acumulación elevada de amiloides mediante una de las siguientes pruebas:
    a. Baja concentración de A?1-42 en el LCR durante la selección
    b. Resultado positivo de amiloides en la prueba con TEP durante la selección (en función de la capacidad del centro para realizar TEP)
    Nota: El valor límite de A?1-42 en el LCR se basará en el valor establecido por el laboratorio central de pruebas de LCR, que se especifica en un manual de laboratorio aparte. Las pruebas de TEP para detectar la presencia de amiloides se evaluarán de manera centralizada por un técnico cualificado para determinar la inclusión según los criterios predefinidos que se indican en el manual de pruebas de diagnóstico por imagen.
    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.
    1. El sujeto recibe un inhibidor de la acetilcolinesterasa (AChE) y/o de la memantina en cualquier momento de la selección o el día 1 antes de la dosis.
    2. El sujeto presenta muestras de cualquier enfermedad cerebral aparte de signos muy tempranos de una posible EA (p. ej., atrofia hipocámpica leve) o los cambios típicos relacionados con el envejecimiento (p. ej., aumento de la intensidad de la sustancia en la RMN). Un radiólogo del centro participante y un radiólogo central deberán interpretar la RMN de la selección en busca de hallazgos de exclusión antes de inscribir al sujeto. Ambas interpretaciones serán revisadas por el investigador; en caso de desacuerdo, se empleará el informe del radiólogo central para determinar la elegibilidad del sujeto en colaboración con el asesor médico del promotor.
    3. Que el sujeto padezca cualquier otro trastorno que pudiera causar una posible deficiencia cognitiva (entre otros, enfermedad cerebrovascular o ictus agudo [según los resultados de la RMN cerebral]).
    4. El sujeto presenta alguna contraindicación para someterse a una RMN (p. ej., prótesis, implantes, claustrofobia, marcapasos)
    5. El sujeto cumple los criterios diagnósticos de demencia o padece un trastorno cerebral que pueda provocar demencia.
    6. El sujeto presenta muestras de rasgos autosómicos dominantes de EA hereditaria (se han identificado mutaciones familiares o en el sujeto antes de la aleatorización).
    7. El sujeto tiene antecedentes de enfermedad o trastorno de tiroides actual, sin controlar, sin evaluar o sin tratar. Los sujetos en tratamiento para enfermedades de tiroides podrán inscribirse después de la revisión de su diagnóstico, con historia clínica del tratamiento por parte del investigador y la conformidad por escrito del monitor médico del promotor, con el fin de garantizar la estabilidad de la enfermedad/tratamiento y su cumplimiento terapéutico.
    8. El sujeto padece deficiencia de la vitamina B12 o de ácido fólico. Una baja concentración de vitamina B12 es motivo de exclusión a no ser que las analíticas de seguimiento (homocisteína y ácido metilmalónico) indiquen que dicho valor no presenta significación fisiológica. Los sujetos en tratamiento con vitamina B12 o ácido fólico podrán inscribirse después de la revisión de su diagnóstico, con historia clínica del tratamiento por parte del investigador y la conformidad por escrito del monitor médico del promotor, con el fin de garantizar la estabilidad de la enfermedad/tratamiento y su cumplimiento terapéutico.
    9. El sujeto presenta trisomía del cromosoma 21 (síndrome de Down).
    10. El sujeto tiene antecedentes de enfermedad mental importante durante los últimos dos años, o padece una en la actualidad, según la última versión del Manual diagnóstico y estadístico de los trastornos mentales (Diagnostic and Statistical Manual of Mental Disorders o DSM) (entre otros, trastornos depresivos graves y trastornos de ansiedad) (los sujetos con ausencia de síntomas o con síntomas mínimos limitados podrán incluirse); o si el sujeto padece o ha padecido esquizofrenia o trastorno bipolar.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in the ADCS-PACC score from baseline.
    El criterio principal de valoración de la eficacia es la variación de la puntuación total de la escala ADCS-PACC que se produzca desde el inicio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 months
    54 meses
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the change from baseline in the CFI total score.
    El criterio secundario de valoración de la eficacia es la variación de la puntuación total de la escala IFC que se produzca desde el inicio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    54 months
    54 meses
    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 concerned8
    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 No
    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
    Última visita último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    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
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-20
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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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