BN29552 A Study of 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
190035
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2015-003034-27
Duration of Study in the UK
5 years, 4 months, 30 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 patients will be recruited into this study globally. Patients will be randomly assigned to either receive crenezumab or placebo as an infusion once every 4 weeks for approximately 2 years during which 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 assessments. 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, anti-dementia medications at baseline, and geographic region.
Five sub-studies are planned in addition to the main study for eligible patients who provide separate informed consent, these are: PET-scans, cerebrospinal fluid (CSF), PET-CSF, ECG and Research.
Following treatment, patients will either be followed-up for another year or will have the option to enter the Open-Label Extension study.
The study is expected to last for approximately 4 years.
In the UK it is expected that 27 participants will be enrolled at 9 participating study centres.
The study is sponsored by F. Hoffman La Roche.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0023
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion