BN40031- CREAD Open Label Extension Study
Research type
Research Study
Full title
A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION OF PHASE III STUDIES (BN29552/BN29553) OF CRENEZUMAB IN PATIENTS WITH ALZHEIMER’S DISEASE
IRAS ID
230833
Contact name
Head of Clinical Trial Regulatory Management
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-002702-12
Duration of Study in the UK
4 years, 11 months, 16 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 open label extension (OLE) study will assess the long-term safety and tolerability of crenezumab administered to all patients with AD who completed Studies BN29552 (CREAD – IRAS ref 190035) and BN29553 (CREAD2 – IRAS ref 218003) and who meet the eligibility criteria for this OLE study.
Patients from Studies BN29552 or BN29553 who discontinued the study prior to completion of the
Study week 105 visit are not eligible for this OLE study.
Patients and all clinical site staff will remain blinded to the original treatment assignment in Studies BN29552 and BN29553 on entry into this open label extension study and until a later time which will be determined by the Sponsor.
The planned number of patients for this OLE study is not expected to exceed 1500 (i.e. the total planned number of patients enrolled to Studies BN29552 and BN29553).
The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 5 years. The end of the study is expected to occur approximately 28 months after the last patient is enrolled.
All Participants will receive crenezumab once every 4 weeks via IV infusion at a dose of 60mg/kg until the end of the study.
During this period patients 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, biomarkers and for the measurement of antibodies directed against crenezumab and other components of the drug product will be obtained from all patients.
In the UK it is expected that approx. 54 participants will be enrolled.
The study is sponsored by F. Hoffman La Roche.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0260
Date of REC Opinion
25 Sep 2018
REC opinion
Further Information Favourable Opinion