221AD301 - Research Participants with Early Alzheimer's Disease
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease
IRAS ID
181087
Contact name
Craig Ritchie
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2015-000966-72
Duration of Study in the UK
6 years, 9 months, 1 days
Research summary
The purpose of the study is to find out whether the study drug aducanumab has the potential to be a helpful treatment that slows down disease progression in research participants with early Alzheimer’s Disease (AD) by comparing it to placebo (inactive medication) and to evaluate its safety (side effects) as well as to find out more about aducanumab.
Each research participant taking part in the study is put into one of three groups and each group is given a different treatment (aducanumab low dose, aducanumab high dose or placebo). Each research participant is put into the treatment group by chance (like flipping a coin).
Study duration for each research participant taking part in the placebo-controlled period only will be approximately 102 weeks (up to an 8 week Screening Period, 76 weeks of placebo or aducanumab dosing, and 18 weeks of follow-up).
There will be the possibility of going into a long-term extension (LTE) part of the study. For research participants who enter the optional LTE, the total duration will be approximately 206 weeks or 47 months (up to an 8 week Screening Period, 76 weeks of placebo or aducanumab dosing, 4 weeks of follow-up, 100 weeks of dose-blind aducanumab dosing, and 18 weeks of follow-up).
This study is sponsored by Biogen. Around 1350 research participants in about 150 study centres globally, will take part in this study.
REC name
Scotland A REC
REC reference
15/SS/0148
Date of REC Opinion
6 Nov 2015
REC opinion
Further Information Favourable Opinion