Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 January 2019 |
Main ID: |
EUCTR2015-000948-42-ES |
Date of registration:
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11/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety Trial of JNJ-54861911 in Participants who are Asymptomatic At Risk for Developing Alzheimer?s Dementia
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Scientific title:
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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 |
Date of first enrolment:
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24/11/2015 |
Target sample size:
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1654 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000948-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Canada
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Denmark
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Finland
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Germany
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Italy
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Japan
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Mexico
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Netherlands
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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31071524 2166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Pharmaceutica N.V. |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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31071524 2166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Pharmaceutica N.V. |
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Key inclusion & exclusion criteria
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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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1400
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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Alzheimer's Disease MedDRA version: 18.0
Level: LLT
Classification code 10001896
Term: Alzheimer's disease
System Organ Class: 100000004852
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Intervention(s)
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Product Name: JNJ-54861911 Product Code: JNJ-54861911 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: . CAS Number: 1200493-78-2 Current Sponsor code: JNJ-54861911 Other descriptive name: JNJ-54861911-AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: JNJ-54861911 Product Code: JNJ-54861911 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: . CAS Number: 1200493-78-2 Current Sponsor code: JNJ-54861911 Other descriptive name: JNJ-54861911-AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: 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).
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Primary end point(s): The primary efficacy endpoint is the change in the ADCS-PACC score from baseline.
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Secondary Objective: 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).
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Timepoint(s) of evaluation of this end point: 54 months
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Secondary Outcome(s)
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Secondary end point(s): The key secondary efficacy endpoint is the change from baseline in the CFI total score.
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Timepoint(s) of evaluation of this end point: 54 months
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Secondary ID(s)
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54861911ALZ2003
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2015-000948-42-SE
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Source(s) of Monetary Support
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Janssen Research and Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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