1289.7 BI409306 compared to donepezil & placebo in Alzheimer's Disease

• Research type

  Research Study

• Full title

  A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to donepezil and placebo in patients with cognitive impairment due to Alzheimer’s Disease.

• IRAS ID

  160235

• Contact name

  Kenneth Scrine

• Contact email

  ken.scrine@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2013-005040-28

• Duration of Study in the UK

  1 years, 3 months, 7 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 donepezil and placebo in patients with mild to moderate Alzheimer’s Disease. This study is designed to compare the effects of 4 different doses of orally administered BI 409306 to current gold standard of care and placebo.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  15/ES/0001

• Date of REC Opinion

  16 Feb 2015

• REC opinion

  Further Information Favourable Opinion