PET SubStudy to WN25203;Amyloid Load in Prodromal Alzheimers Disease
Research type
Research Study
Full title
Sub Study to study WN25203,using positron emission tomography (PET) with an amyloid tracer to assess changes in amyloid load over time in subjects with Prodromal Alzheimer's Disease
IRAS ID
60183
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
This is a sub study to WN25203 of gantenerumab (RO4909832), where participants who have consented for the main study, also have an opportunity to consent to this sub study and will undergo Positron Emission Tomography (PET) imaging using a radiotracer that labels (attaches) to amyloid in the brain. The main purpose of this research study is to look at the changes in amyloid load over time using PET, in subjects with prodromal alzheimers who have been treated with gantenerumab (RO4909832). Study participants, dependant on their APOE genotype (APOE is a genotype which may have something to do with the way a patient will react to the drug and which will be ascertained at screening in the main study), will receive either 105mg or 225mg gantenerumab or placebo for the study duration as part of the main study.
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. For patients who do not meet the criteria for Alzheimers Disease (AD), they may be in the early stages of AD, the so called prodromal phase of Alzheimers.
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 at screening, & after the 6th, 16th & 26th doses to undergo their PET scans. They will receive in total 4 PET scans.
The study is being conducted at nine sites in the UK.REC name
South Central - Oxford B Research Ethics Committee
REC reference
10/H0605/58
Date of REC Opinion
13 Oct 2010
REC opinion
Further Information Favourable Opinion