Yesterday, the Food and Drug Administration (FDA) released a new guidance document for how researchers can best approach drug development for early Alzheimer's disease. Specifically, the FDA is looking at, “including strategies for trials incorporating patients with Alzheimer's who haven't experienced any visible impairment (in the form of cognitive or functional deficits), but who may be identified through the use of sensitive cognitive screening, imaging tests, or biomarkers.”
This is an extremely important policy development for our community.
Understanding the value and importance of taking every possible step to speed the development of effective treatments for those facing Alzheimer's and related dementias, the Alzheimer's Impact Movement (AIM) and the Alzheimer's Association are very encouraged by this action.
The Alzheimer's research field has rapidly advanced since the FDA released an earlier draft guidance in 2013, and these new recommendations reflect these developments. For example, we now can reliably detect biomarker changes that indicate people are on the Alzheimer's/dementia pathway well before changes appear in cognition and function. Researchers believe the most effective time to stop the disease is early in its progression — before symptoms have appeared.
This draft FDA guidance, once finalized and adopted, will be very important for enabling, encouraging and eventually evaluating clinical trials for exactly this kind of early treatment intervention in Alzheimer's disease. In releasing these guidelines, the FDA is clearly in step with the evolution of the Alzheimer's drug development field toward early detection and early intervention — and that the field is still evolving. Additionally, once finalized and adopted, these guidelines will give confidence to the drug development enterprise — including industry and academic researchers — that appropriate support and guidance exists for them to assertively move into this area of investigation.
In a closely related initiative, the Alzheimer's Association is working right now with the FDA, the National Institute on Aging (NIA) and other global experts in the field, on revised guidelines for the definition of Alzheimer's disease in research settings.
In addition, the draft FDA guidance calls for “diagnostic criteria that reliably define a population with early Alzheimer's, including the earliest stages characterized only by pathophysiological changes.” This new research framework will provide that reliable diagnostic criteria for research settings.
The FDA is seeking public comment on their proposal for the next 90 days. Working with the Alzheimer's Association, AIM will be submitting our official comments to the government to ensure the most effective treatments are made available to those living with dementia as soon as possible.