BI 425809 and placebo in patients with Alzheimer's Disease
Research type
Research Study
Full title
A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy and safety of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer’s Disease.
IRAS ID
204452
Contact name
Rohan Van Der Putt
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2015-005438-24
Duration of Study in the UK
2 years, 3 months, 16 days
Research summary
The purpose of this trial is to investigate the effects of a new investigational drug, called BI 425809) on cognition in patients with mild to moderate Dementia of Alzheimer’s Type. Patients will be recruited who have had a diagnosis of mild to moderate Alzheimer’s dementia according to the recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Each patients participation in the trial will last approximately 16 weeks and require approximately 7-10 visits to the trial clinic. Patients will be randomly assigned to receive either the investigational BI 425809 or the placebo in one of the following five groups 1) One group will receive BI 425809 2 mg dose once daily 2) One group will receive BI 425809 5 mg dose once daily, 3) One group will receive BI 425809 10 mg dose once daily 4) One group will receive BI 425809 25 mg dose once daily and finally 5) One group will receive placebo. The Primary endpoint will be a change from baseline in ADAS-cog13 (Alzheimer’s Disease Assessment Scale-cognitive subscale) total score after 12-week treatment. Eligible patients must have a reliable study partner who is in close contact with the patient and who must also agree to take part.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1310
Date of REC Opinion
9 Sep 2016
REC opinion
Further Information Favourable Opinion