An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia (EARLY)

Trial Purpose and Description

This is a multi-center, phase 2b/3, randomized, double-blind, placebo-controlled, parallel group study investigating the efficacy and safety of JNJ-54861911 in subjects who are asymptomatic at risk for developing Alzheimer's disease. This study will enroll approximately 1650 subjects across all sites. The primary objective is to determine whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment.

Ages: 60 - 85 years

Gender: Both


Eligibility Criteria

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, ε4 allele (APOE ɛ4) 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)

http://www.alzheimers.yale.edu


Janssen Research & Development, LLC

Start Date: 09/25/2017

End Date: 04/01/2023

Last Updated: 02/22/2018

Study HIC#: 1608018299

Get Involved

For more information about this study, contact:
Srinath Ramanan
+1 203-764-8100
srinath.ramanan@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Christopher H Van Dyck

Principal Investigator

Sub-Investigators