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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Alzheimer's Disease
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

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

Purpose
The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.
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CW ID: 222920
Date Last Changed: February 3, 2017

Clinical Trial Snapshot

Phase
2/3
Gender
Both Male and Female
Age
60 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Janssen Research & Development, LLC
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Participant must have a global Clinical Dementia Rating Scale- (CDR) score of '0' at Screening
  • Participants 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 apolipoprotein E, e4 allele (APOE ?4) genotype, c) a previously known biomarker status demonstrating elevated amyloid accumulation in cerebrospinal fluid (CSF) or positron emission tomography (PET)
  • Participant 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
  • Participants must have evidence of amyloid accumulation by means of either: a) low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at Screening; b) a positive amyloid positron emission tomography (PET) scan at Screening (depending on the site's PET capability) by visual read
  • Participant must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline

    Exclusion Criteria:

  • Participant is receiving an acetylcholinesterase (AChE) inhibitor and/or memantine at any time during Screening or Day 1 predose
  • Participant has evidence of any brain diseases, other than potential very early signs of Alzheimer's Dementia (AD) (example. mild hippocampal atrophy) or typical age-related changes (e.g. mild white matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit (including, but not limited to vascular encephalopathy or large strokes (as imaged by cerebral MRI)
  • Participant has any contraindications for MRI (example, prostheses, implants, claustrophobia, pacemaker)
  • Participant has met criteria for dementia or has a brain disorder that can cause dementia
  • Participant has evidence of familial autosomal dominant AD (mutation identified in the family and/or participant prior to randomization)
  • Contact

    Jill Smith
    University of South Florida - USF Health Byrd Alzheimer's Institute
    4001 Fletcher Ave
    Tampa, FL 33613
    Phone: (813) 974-1294

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