1289.5 BI409306 compared to placebo in Alzheimer's Disease
Research type
Research Study
Full title
1289.5: A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer’s Disease
IRAS ID
160230
Contact name
Kenneth Scrine
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2013-005031-24
Duration of Study in the UK
1 years, 10 months, 22 days
Research summary
This is a Phase II, multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally
administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer’s Disease. Currently there are no approved treatments approved for the prodromal stages of Alzheimer's disease. However, those with prodromal AD have an increased risk of eventually developing Alzheimer's dementia. Therefore, a symptomatic treatment that delays the progress of these first symptoms cause by the underlying pathology might provide a substantial benefit to such patients. This study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo because there is no approved treatment
for prodromal AD available so far.REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1141
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion