BN29553 (CREAD-2) - Crenezumab in patients with Prodromal to Mild AD
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
IRAS ID
218003
Contact name
Naji Tabet
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-003288-20
Duration of Study in the UK
5 years, 7 months, 1 days
Research summary
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 crenezumab 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 crenezumab or placebo as an infusion once every 4 weeks 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 crenezumab and other components of the drug product will be obtained from all patients. Patients will be stratified by dementia status, APOE gene, anti-dementia medications at baseline and geographical region.
There are 4 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.
These are: PET-substudy, TAU-PET-substudy, CSF-substudy and Research-substudy.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 36 participants will be enrolled.
The study is sponsored by F. Hoffman La Roche.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/0380
Date of REC Opinion
7 May 2017
REC opinion
Further Information Favourable Opinion