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    Summary
    EudraCT Number:2014-004274-41
    Sponsor's Protocol Code Number:54861911ALZ2004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-12
    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 number2014-004274-41
    A.3Full title of the trial
    A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer's Disease Spectrum
    Estudio de extensión, multicéntrico, aleatorizado, con dos períodos, doble ciego controlado con placebo y abierto, para determinar la seguridad y tolerabilidad a largo plazo de JNJ-54861911 en sujetos en el espectro de enfermedad de Alzheimer temprana
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer?s Disease Spectrum
    Estudio de extensión para evaluar la seguridad y tolerabilidad a largo plazo de JNJ-54861911 en participantes en el espectro de con enfermedad de Alzheimer temprana
    A.4.1Sponsor's protocol code number54861911ALZ2004
    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 Cilag, S.A:
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number3491722 8100
    B.5.5Fax number3491722 8628
    B.5.6E-mailagonza45@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 INNN/A
    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 INNN/A
    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.
    Enfermedad de Alzheimer (EA) es una enfermedad neurodegenerativa asociada con envejecimiento. Pacientes con EA sufren déficit cognitivo, pérdida de memoria y problemas de comportamiento como ansiedad.
    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 study is to evaluate the long-term safety and tolerability of JNJ 54861911 in participants in the early Alzheimer?s disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.
    El objetivo de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de JNJ-54861911 en participantes en el espectro de enfermedad de Alzheimer temprana (EA [enfermedad progresiva del cerebro que destruye lentamente la memoria y las habilidades de pensamiento, y, finalmente, incluso la capacidad de llevar a cabo las tareas más simples]) que hayan completado un ensayo clínico fase 1b o 2 con JNJ-54861911y que estén dispuestos a continuar con el tratamiento asignado
    E.2.2Secondary objectives of the trial
    To assess PK/PD affects and provide ongoing access to JNJ-54861911.
    Evaluar efectos FC/FD y proporcionar acceso continuado a JNJ-54861911
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants in the early Alzheimer?s disease (AD) spectrum at time of enrollment under the parent protocol and according to its inclusion and exclusion criteria, must have very recently completed their treatment in a phase 1b or phase 2 JNJ-54861911 clinical study (e.g., 54861911ALZ2002) under the parent protocol. Enrollment in the extension study should be completed (Day 1 Treatment Period 1) as soon as possible, but within 6 weeks, following completion of their treatment period under the parent protocol. If not defined under the parent protocol, completion of the treatment period is defined as having completed all study related procedures of the last visit of the treatment period under the parent protocol. A screening phase of up to 12 weeks may be allowed following written approval of the Sponsor
    - Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
    - Each Participants (or their legally acceptable representative and caregiver depending on disease state and local requirements) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
    - Participants must have a reliable informant (relative, partner, or friend). The informant must be willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or other audio/visual communication). The informant must have sufficient contact such that the Investigator feels he/she can provide meaningful information about the participant?s daily function. If possible, an alternate informant meeting these criteria who can replace the primary informant should be identified prior to randomization
    Los participantes en el espectro de enfermedad de Alzheimer (EA) temprana en el momento del reclutamiento con arreglo al protocolo original y conforme a sus criterios de inclusión y exclusión, tendrán que haber completado muy recientemente su tratamiento en un estudio clínico de fase 1b o fase 2 con JNJ-54861911 (p. ej., 54861911ALZ2002) con arreglo al protocolo original. El reclutamiento en el estudio de extensión tendrá que completarse (Día 1 Período de Tratamiento 1) lo antes posible, pero dentro de las 6 semanas siguientes a la finalización del período de tratamiento con arreglo al protocolo original. Si no se ha definido ya en el protocolo original, el período de tratamiento se considerará finalizado cuando se hayan completado todos los procedimientos relacionados con el estudio de la última visita del período de tratamiento con arreglo al protocolo original. La fase de selección podrá extenderse durante 12 semanas tras obtener la aprobación por escrito del promotor. -Los participantes deben ser capaces de cumplir las prohibiciones y limitaciones especificadas en este protocolo y estar dispuestos a cumplirlas. -Cada participante (o su representante legal y cuidador dependiendo del estado de su enfermedad y de los requisitos locales) deberá firmar un documento de consentimiento informado (DCI) en el que manifieste que entiende la finalidad y los procedimientos necesarios para el estudio y que está dispuesto a participar en el estudio. -Los participantes deben tener un informador fiable (familiar, pareja o amigo). El informador ha de estar dispuesto a participar como fuente de información y tener, como mínimo, un contacto semanal con el participante (el contacto podrá ser en persona, por teléfono o por comunicación audiovisual). El informador ha de tener un contacto suficiente para que el investigador considere que puede aportar información importante sobre las funciones cotidianas del participante. En la medida de lo posible, antes de la aleatorización deberá identificarse un informante suplente que cumpla estos criterios y que pueda sustituir al informante principal.
    E.4Principal exclusion criteria
    - Any condition or situation which, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject?s participation in the study
    - The use of concomitant medications known to prolong the QT/QTc interval
    -Trastorno o situación que, en opinión del investigador, pueda suponer un riesgo importante para el paciente, confundir los resultados del estudio o interferir de forma significativa en la participación en el estudio
    -Uso de medicamentos concomitantes que se sabe que prolongan el intervalo QT/QTc.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
    Número de participantes con eventos eventos adversos (EA) o eventos adversos graves (EAG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 up to 30 days after last dose of study drug administration
    Día 1 hasta 30 días después de la última dosis de la administración de fármaco del estudio
    E.5.2Secondary end point(s)
    1) Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels
    2) Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels
    3) Maximum Plasma Concentration (Cmax) of JNJ-54861911
    4) Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau)
    5) Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety
    Cambio porcentual desde el momento basal en líquido cefalorraquídeo (LCR) de niveles de Beta Amiloide (ABeta) (1-37, 1-38, 1-40, 1-42) y de fragmentos (sAPP-alfa, sAPP beta)de Proteína Precursora de Amiloide soluble (sAPP), niveles totales de sAPP 2) Cambio porcentual desde el momento basal en plasma de niveles de ABeta 1-40 y fragmentos sAPP (sAPP-alfa, sAPP-beta), niveles totales de sAPP 3) Concentración plasmática máxima (Cmax) de JNJ-54861911 4) Área bajo la curva concentración-tiempo plasma/CSF desde el tiempo 0 hasta tau horas tras la dosis (AUCtau) 5) Relación entre los cambios en el LCR y plasma de especies de ABeta y fragmentos sAPP y la seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue)
    2) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue)
    3) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue)
    4) Day 0 and Month 12 in treatment period 1; Every 24 weeks and 96 weeks in treatment period 2 up to end of treatment visit (until registration of JNJ-54861911 or any safety issue)
    5) Day 1 up to 30 days after last dose of study drug administration
    1), 2), 3) y 4) Día 0 y Mes 12 en Período 1 de tratamiento; cada 24 y 96 semanas en Periodo 2 de tratamiento hasta visita fin tratamiento (hasta registro de JNJ-54861911 o hasta cualquier motivo de seguridad 5) Desde el Día 1 hasta 30 días después de la última dosis administrada de medicación del estudio
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Treatment period 1 is double blind; Treatment period 2 is open-label
    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 trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial days8
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2015-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-28
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