New guidance provides clarity on endpoints, will help spur pharmaceutical innovation for Alzheimer’s treatments

NEW YORK, NY (17 May 2018) – The Global Coalition on Aging (GCOA) today submitted comments to the U.S. Food & Drug Administration (FDA) supporting the administration’s new regulatory guidance document on early Alzheimer’s disease and calling for similar updates for related dementias. The draft guidance clarifies the clinical endpoints required for early Alzheimer’s disease treatments, reflecting the latest understanding of the disease’s progression, and opening opportunities for increased pharmaceutical innovation.

“By issuing this new draft guidance, the FDA has demonstrated its commitment to rapidly advancing innovation in Alzheimer’s drug development,” said Michael Hodin, CEO of the Global Coalition on Aging. “As Alzheimer’s affects more and more of us across society as the population ages, researchers and regulators alike must adapt based on what the science has taught us. We applaud the FDA for its leadership in recognizing the urgency to update regulations and create a path for faster and smarter processes that remove barriers to innovation.”

GCOA is also calling for the FDA to make advancements in clinical trial enrollment: first, by developing common diagnostic criteria for enrollment in clinical trials. Secondly, GCOA is recommending more aggressive focus on earlier detection and diagnosis to help ensure adequate participation from people with Alzheimer’s in clinical trials. By collecting data earlier in the progression of dementia, researchers can pinpoint drug targets more effectively and efficiently.

GCOA’s comments are in line with findings from the Dementia Innovation Readiness Index,a collaborative report published by GCOA and Alzheimer’s Disease International (ADI) in 2017. It analyzed the readiness of different countries to integrate innovative solutions for dementia treatment, prevention and care into their healthcare and policy systems. In 2017, the Index focused on the G7 countries – Canada, France, Germany, Italy, Japan, and the United Kingdom. In 2018, the Index will expand to focus on select G20 countries – Argentina, Brazil, China, India, and Saudi Arabia. The 2018 edition of the Index will be released at ADI’s annual conference in Chicago this July.