Most National Alzheimer’s Project Studies Not Looking to Show Clinical Benefit, Scientists Argue

Most National Alzheimer’s Project Studies Not Looking to Show Clinical Benefit, Scientists Argue
Two physicians — one at the University of Pennsylvania's Perelman School of Medicine and the other with the University of Michigan — argue in a recent opinion piece that the National Alzheimer Project Act (NAPA), as it now stands, has resulted in potential treatments for Alzheimer’s disease being tested without a clear requirement that these therapies show proof of meaningful clinical benefit. In the viewpoint, “Unfinished Business in Preventing Alzheimer's Disease,” Jason Karlawish, MD, and Kenneth M. Langa, MD, PhD, warned that this failure could lead to treatments being approved that end up being much more costly than they should be.  The article was published in JAMA Internal Medicine. NAPA, signed into law in 2010 by President Barack Obama, calls for new treatments to slow or prevent the disease by 2025 — and five clinical trials are now underway toward that goal, the doctors write. But only one of the five (NCT02565511) is using scientific measures of clinical benefit (defined as demonstrated improvements in day-to-day function). The others are using a "surrogage" measurement that falls under the U.S. Food and Drug Administration's (FDA) accelerated approval program, established during the early years of HIV research to speed the development of needed drugs. The problem is that this measure looks at therapeutic effect, which is a predictor of clinical benefit rather a m
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