A Study of Gantenerumab in Patients with Mild Alzheimer Disease
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, EFFICIACY AND SAFETY STUDY OF GANTENERUMAB IN SUBJECTS WITH MILD ALZHEIMER’S DISEASE
IRAS ID
142468
Contact name
Richard Perry
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-003390-95
Duration of Study in the UK
5 years, 0 months, 12 days
Research summary
Reserach Summary
Can gantenerumab slow disease progression in patients with mild Alzheimer’s disease?
Alzheimer’s disease is a type of dementia that typically starts with the loss of memory and language which becomes worse over time. Patients become more dependent on their caregivers and less able to look after themselves. There is no known cure for this disease and current treatments can only help with the symptoms.
Alzheimer’s disease is thought to be due to a build-up of certain chemicals in the brain, which can cause deposits of these chemicals to form. Gantenerumab is a monoclonal anti-body (a type of drug) thought to reduce and breakdown these deposits in the brain, which has been given to around 1000 patients in studies so far.This study will compare gantenerumab with a dummy medication, to see if it is able to slow the progression of Alzheimer’s disease, as well as to check that it continues to be safe.
To be eligible for the study, patients would need to have a diagnosis of mild Alzheimer’s disease. They could be currently taking medication for this. Patients would be seen at their local hospital or memory clinic, where the study is taking place. They would be given the study medication, or the dummy medication by an injection every 4 weeks for 2 years, and then continue to be followed up for another year after that. Patients would regularly undergo memory tests and blood tests, with MRI scans less often and annual lumbar punctures.
The study is being funded by Roche Products Ltd and is being run in countries across the world.
Summary of Results
Results were posted on clinicaltrial.gov on 8th April 2022. Results will go live on 16th April 2022 and then will be made available on the ForPatients website.
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REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0037
Date of REC Opinion
26 Feb 2014
REC opinion
Further Information Favourable Opinion