Phase 3 study to investigate the effects of BAN2401 in AD patients.
Research type
Research Study
Full title
A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
IRAS ID
261974
Contact name
Stuart Ratcliffe
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2018-004739-58
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
This study is a multi-centre, double blind, placebo controlled, parallel-group study in patients with early Alzheimer's Disease. Patients will be randomized across to 2 treatment groups (placebo and study drug BAN2401).
The duration of the study will be up to 23 months (up to 2 months for screening, 18 months of treatment, and a follow-up visit at 3 months post treatment).
An extension phase will be available for patients who complete the full 18 months of treatment in the study and will continue for up to 2 years, or until commercial availability of BAN2401, or until a positive risk-benefit assessment in this indication is not demonstrated.
A total of 1566 patients will take part in the study. There will be approx.200 investigational sites including North America, Europe, Asia-Pacific, and China.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0272
Date of REC Opinion
12 Jun 2019
REC opinion
Favourable Opinion