WN39658 - Gantenerumab in patients with prodromal to mild AD
A Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of gantenerumab in patients with prodromal to mild Alzheimer's Disease
F Hoffmann-La Roche Ltd
Duration of Study in the UK
5 years, 4 months, 23 days
Alzheimer's Disease (AD) is the most common cause of dementia. It affects an estimated 26.6 million worldwide. Current approved medical therapies may temporarily improve the symptoms of AD in some patients, but do not modify progression of the disease.
This Phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group study aims to evaluate the safety and efficacy of gantenerumab in patients with prodromal to mild AD.
A total of 750 participants will be recruited into this study globally. Participants will be randomly assigned to either receive gantenerumab or placebo as subcutaneous injection (once every 4 weeks then 2-weekly after 9 months) for 100 weeks (approximately 2 years). During this period they will undergo tests to monitor safety (including standard safety blood tests, ECG, MRI-scans), as well as tests for cognition, function, and quality of life assessment. Blood samples for assessment of pharmacokinetics, pharmacodynamics, biomarkers, and for the measurement of antibodies directed against gantenerumab and other components of the drug product will be obtained from all patients.
Patients will be stratified by stage of disease (prodromal vs mild), APOE gene status, anti-dementia medications at baseline and geographical region and participation in longituinal amyloid positron emission topography (PET) substudy.
There are 2 sub-studies linked to the main study. These are are optional to sites and to participant. The participant will need to give express consent to each.
Following treatment, participants will either be followed-up for another year or will have the option to enter the open label extension study where all participants can receive active drug.
The study is expected to last for approximately 4 years. In the UK it is expected that up to 90 participants will be enrolled.
South Central - Oxford C Research Ethics Committee
Date of REC Opinion
21 May 2018
Further Information Favourable Opinion