WN25203 - Proof of Efficacy of RO4909832 in prodromal alzheimer's
Research type
Research Study
Full title
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease
IRAS ID
52395
Contact name
Richard Perry
Contact email
Sponsor organisation
F Hoffman-La Roche Ltd Basel
Eudract number
2010-019895-66
Duration of Study in the UK
4 years, 2 months, days
Research summary
The main purpose of this research study is to test the safety and effectiveness of the study medication RO4909832 (gantenerumab) in prodromal Alzheimer’s disease. For patients who do not meet the criteria for Alzheimer’s dementia (AD), they may be in the early stages of AD, the prodromal phase of Alzheimer’s disease.
Alzheimer's Disease is the most common form of dementia in the elderly and during the course of the disease the chemistry and structure of the brain changes. This results in symptoms such as loss of memory, mood changes and communication problems.
Most forms of dementia cannot be cured, although research is continuing into studying new treatments.
This study will last for approximately 112 weeks (2 years and 5 months), which includes 100 weeks of treatment and 12 weeks of follow up. Study participants will be seen every 4 weeks during treatment. Study participants, dependant on their genotype (which will be ascertained at screening), will receive either 105mg or 225mg gantenerumab or placebo for the study duration.
The study is being conducted at seven sites in the UK.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
10/H0605/59
Date of REC Opinion
13 Oct 2010
REC opinion
Further Information Favourable Opinion