FDA Provides New Guidance on Developing Alzheimer's Drugs

The Food and Drug Administration (FDA) today issued a proposal designed to assist pharmaceutical companies engaged in developing new treatments for individuals who are in the early stages of Alzheimer's disease—that is, before the onset of overt dementia. The guidance explains the agency's current thinking on how researchers can identify and select patients for participation in clinical trials of new medications. According to Russell Katz, M.D., director of the Division of Neurology Products in the FDA Center for Drug Evaluation and Research, the guidance reflects the agency's belief 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. It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients."

Katz noted as well that the guidance, which is still in draft form and available for public comment, "is intended to serve as a focus for continued discussion between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public."

The complete text of the FDA guidance can be read here. To read about treatment and diagnosis of Alzheimer's disease, see Clinical Manual of Alzheimer Disease and Other Dementias, from American Psychiatric Publishing.

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