The Efficacy and Safety of Solanezumab vs Placebo in Prodromal AD
Research type
Research Study
Full title
A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab versus Placebo in Prodromal Alzheimer’s Disease
IRAS ID
210526
Contact name
Alan Lenox-Smith
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-000108-27
Duration of Study in the UK
4 years, 7 months, days
Research summary
Study H8A-MC-LZBE is a multicentre, randomized, double-blind, placebo-controlled Phase 3 trial of Solanezumab. This study is being conducted to find out if Solanezumab could help slow down the progression of Alzheimer’s disease (AD) by removing a protein called amyloid-beta that builds up in the brain. Amyloid-beta protein is thought to be one of the causes of AD.
The study is international and will include about 2450 participants worldwide and 66 participants in the UK. Men and women aged 55-85 years old who may have early AD will be included in this study. Study participants must have a reliable study partner with whom they live or have regular contact.Study participants will receive either solanezumab or placebo every 4 weeks given via a slow drip into the vein (called an intravenous infusion). The placebo will look exactly the same as solanezumab but will contain no medicine. There will be a 50:50 chance of receiving either solanezumab or placebo. Neither the study participant nor the study doctor will know which treatment the study participant has been randomly assigned to receive. As patients in this study will have the early form of Alzheimer’s disease it is not expected that they will be on other treatments for AD when they enter the study.
Participants are expected to be in the study for just over 2 years. Study assessments will include memory and thinking tests, questionnaires, blood tests, physical and neurological examinations, ECGs (electrical tracings of the heart rhythm), MRI scans of the brain, and either a PET scan (another scan of the brain used to look for the presence of amyloid) or a lumbar puncture (which is another way of looking for amyloid in the brain).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1767
Date of REC Opinion
28 Dec 2016
REC opinion
Further Information Favourable Opinion