FDA calls for more research in early Alzheimer’s disease

The FDA is calling for further research on earlier stages of Alzheimer’s disease to attack the disorder head on.

Despite extensive efforts to develop new treatments for Alzheimer’s, options remain limited, according to the agency. The FDA has approved five drugs for Alzheimer’s disease in the last 20 years, with the most recent approval in 2003.

“There may be a window of opportunity to affect the disease before people experience symptoms,” Eric Bastings, MD, deputy director of FDA’s Division of Neurology Products, said in a press release.

To increase research efforts in early Alzheimer’s disease, the FDA issued a draft guidance in 2013 to help companies conduct clinical trials that focus on before the onset of dementia.

The goal of the draft guidance was to serve as a focus for continued discussions of early stage Alzheimer’s disease among the FDA, new drug sponsors, academics and the public.

“Earlier and more precise identification of patients with early changes in the brain who will go on to develop Alzheimer’s is important for the success of these clinical studies,” Billy Dunn, MD, director of FDA’s Division of Neurology Products, said in the release. “We hope that earlier interventions, before further extensive damage to the brain sets in, will be more successful. We’re very excited about the potential for this research to result in safe and effective treatments for early Alzheimer’s disease.”