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FDA releases guidelines for developing Alzheimer’s drugs

The FDA issued a proposal today to assist drug companies that are developing new treatments for patients in the early stages of Alzheimer’s disease.

“The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer’s disease before there is too much irreversible injury to the brain,” Russell Katz, MD, director of the FDA’s division of neurology products, said in a press release. “It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients.”

The draft proposal, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” discloses the FDA’s position on how researchers can identify patients with early Alzheimer’s disease or patients at risk for the disorder who can participate in clinical trials. The draft also includes guidelines on clinical outcome measures, trial designs and the role of biomarkers.

The FDA currently requires that treatments show an effect on abnormal thinking in patients with overt dementia and also on how well they function. Trials must aim to ensure that any beneficial effect on thinking is linked to clinically meaningful outcomes for patients, such as an improvement in cognition or how patients feel or function.

“This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public,” Katz said. “The FDA is committed to vigorously addressing Alzheimer’s disease and will work with industry to help develop new treatments in this early population as expeditiously as possible.”

The draft guidance, which is open to public comment for 60 days, can be viewed here.