JNJ-54861911ALZ2003 - 'EARLY' - Alzheimer's Dementia Study
Research type
Research Study
Full title
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
IRAS ID
189114
Contact name
Pearson Stephen
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2015-000948-42
Duration of Study in the UK
7 years, 2 months, 29 days
Research summary
Alzheimer’s disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits and memory loss, as well as by behavioural problems such as anxiety. Amyloid-beta fragments are proteins found in the brain which are sometimes associated with neurological damage and thought to be an important indicator associated with Alzheimer’s disease.
This is a phase 2b/3, multi-centre, double-blinded, placebo controlled, randomised, parallel-group study designed to assess the efficacy and safety of once daily, oral administration of 2 dosage levels of test drug, JNJ-54861911 (10 and 25 mg) over approximately 4.5 years treatment in amyloid-positive subjects (60 to 85 years of age) who are asymptomatic, i.e. at risk of AD but experiencing no symptoms currently.
There are 3 treatment groups assigned randomly in a 1:1:1 ratio:- one group receiving JNJ-54861911 10 mg, one JNJ-54861911 25 mg and one group who will receive placebo.
The primary aim of this study is to determine whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment.
The study has 3 phases: Screening (90 days), Double Blinded Treatment (4.5years), and Follow-up (a visit 7 to 28 days after the last dose of study drug). Planned maximum subject participation is 58 months.
The study will be conducted in an outpatient setting. Following screening and baseline evaluations, eligible subjects will be randomised into one of the 3 treatment groups. Subjects will be required to take their assigned drug once daily for approximately 4.5 years and will attend study clinic for assessments, 21 times within this period. Following the treatment period, subjects will stop taking the medication and return to the study clinic for a follow up examination 1-4 weeks after their last dose of study drug. Subjects will then be contacted every 6 months by telephone, in order to assess general/cognitive health, for a further 5 years.This is a multicentre, international study with the aim of achieving approximately 1,650 randomised subjects (550 in each treatment group).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0659
Date of REC Opinion
3 Mar 2016
REC opinion
Further Information Favourable Opinion