IMI launching project for adaptive Alzheimer's trial

During the G8 Dementia Summit, the EU's Innovative Medicines Initiative (IMI) unveiled a EUR 53 million ($72.7 million) project (EPOC-AD) aimed at developing an adaptive proof-of-concept trial for Alzheimer's disease (AD) drug candidates. IMI said the aim is to conduct a trial to efficiently identify treatments or combinations "with sufficient promise" at preventing or halting the progression of AD to warrant further testing. The project will comprise a registry, a longitudinal study and an adaptive trial, which is expected to enroll about 1,500 patients. IMI said the project will also help efficiently determine subgroups in which candidate drugs would be most effective, and to identify, validate and qualify AD biomarkers. IMI said use of an adaptive trial has already been proven effective with I-SPY 2, an adaptive trial aimed at rapidly and inexpensively developing data to support small Phase III trials of new neoadjuvant therapies for locally advanced breast cancer. Two compounds have "graduated" from I-SPY 2. (see above)

The EU's Framework Programme 7 (FP7) will provide EUR 28 million ($38.4 million) in funding for the five-year project, with EUR 25 million ($34.3 million) coming from in-kind contributions from companies participating in the project. The Alzheimer's project is part of IMI's recently launched eleventh call for proposals. Applications are due April 8, 2014 (see BioCentury Extra, Dec. 12). ...