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FDA Offers Guidance on Developing Drugs for Alzheimer’s Disease

Draft proposal focuses on treatments for early-stage disease (Feb. 7)

The FDA has issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease (AD), before the onset of noticeable (overt) dementia.

AD slowly destroys memory and thinking skills, and eventually the ability to carry out the simplest tasks of daily living. In most people with AD, symptoms first appear after age 60. AD is the most common cause of dementia among older people.

The draft guidance explains the FDA’s current thinking about the way researchers can identify and select patients with early AD — or those at risk of developing the disease — for participation in clinical trials. It is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public.

In recent years, the research community has tried to find ways to identify patients with early AD using criteria that are based on biological indicators (biomarkers). Researchers have also tried to develop sensitive clinical measures that can detect subtle mental decline.

For drugs designed to treat patients with overt dementia, the FDA currently requires that treatments not only show an effect on abnormal thinking, but also how well patients function. The goal for these trials is to ensure that any beneficial effect on thinking is associated with a clinically meaningful outcome for the patient, such as an improvement or lack of decline in how patients feel or function.

However, because patients with early AD have little or no impairment of global functioning, it is difficult to assess changes in function in these patients. This can make it difficult to determine whether the effect of a given treatment is clinically important.

The FDA is seeking public comment on the draft guidance for 60 days. In finalizing the guidance document, the agency will consider the information received from the public.

Sources: FDA; February 7, 2013; and Draft Guidance; February 2013.

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