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The Alzheimer's Divide

 
• By Mark Ratner

Issues of clinical trial design are at the forefront in Alzheimer's drug development. Researchers and investors are weighing the impact of late-stage failures, even as significant unknowns remain about disease mechanism and the correlation of biochemical markers and clinical effects. A fundamental question hangs over AD drug development, which is unique in many respects: in deciding how to move from Phase II into Phase III, what can you know and how can you know it?

Speaking to a group of investors following the July 2008 International Conference on Alzheimer’s Disease (ICAD), Lon Schneider, MD, of the Keck School of Medicine at the University of Southern California compared the current odds of success in late-stage Alzheimer’s Disease drug development to a Major League baseball player at the plate: he is unlikely to get a hit but that doesn’t mean he won’t get one.

The recent Phase III clinical trials in AD have been strikeouts: tarenflurbil (Flurizan), from Myriad Genetics Inc., failed in Phase III in June 2008, as did tramiprosate (3APS, Alzhemed),...

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