Alzheimer’s is a complex and frustrating disease that robs people of their memories and families of their loved ones.
Leading Experts Discuss Clinical Meaningfulness in Drug Development for Early Alzheimer’s Disease
Published November 6, 2014
November 6th, 2014 – ACT-AD Coalition Hosts Its Seventh Annual Meeting
Bethesda, Md., November 6, 2014 –– A coalition of more than 50 nonprofit organizations representing patients, family caregivers and scientists met with representatives from the Food and Drug Administration (FDA) to explore how to better treat Alzheimer’s disease. The meeting, cohosted with the Society for Women’s Health Research, marks the seventh annual collaboration between U.S. regulators and the coalition known as ACT-AD (Accelerate Cure/Treatments for Alzheimer’s Disease).
The goal of this year’s meeting was to gain insights from diverse parties in the research and development process in order to improve clinical trials of Alzheimer’s disease therapeutics. The specific focus of the meeting was on balancing the needs of all stakeholders in the drug development process who seek more effective treatments and forging agreement on current strategies for demonstrating clinical meaningfulness in existing trials of early Alzheimer’s patients and how they might inform approaches for future trials.
“Since the FDA released a draft guidance on early Alzheimer’s disease in 2013, it has been reaching out to the broader Alzheimer’s community to help formulate strategies for earlier treatment. This gathering was an important step to advance the dialogue on how we can improve approaches to defining and measuring what is clinically meaningful in an Alzheimer’s intervention,” says Daniel Perry, of the Alliance for Aging Research and chair of the ACT-AD Coalition.
Experts who presented included:
- Kun Jin, Ph.D., U.S. Food and Drug Administration (FDA), on progress in building an integrative Alzheimer’s trial database
- Richard Keefe, Ph.D., Duke University, on the challenges with defining clinical meaningfulness in CNS diseases
- Paul Aisen, M.D., UCSD, on research on declines in cognition and function in early AD
- A panel moderated by Aisen that discussed clinical meaningfulness in current trials and ways to
foster efforts to develop tools for use in future trials. Panelists included: Eric Bastings, M.D., FDA; Billy Dunn, M.D., FDA; Suzanne Hendrix, Ph.D., Pentara; Janice Hitchcock, Ph.D., Eli Lilly; Nicholas Kozauer, M.D., Quintiles; and Ranjit Mani, M.D., FDA
ACT-AD and its partners will provide a more detailed summary of the results of today’s meeting at a future date. For more information, please visit the coalition’s website or call 202-293-2856.
ACT-AD is a coalition of more than 50 national organizations representing patients, providers, caregivers, consumers, older Americans, researchers and employers seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The coalition is directed by an Advisory Council made up of representatives from the Alliance for Aging Research (AAR), Alzheimer’s Foundation of America (AFA), American Society on Aging (ASA), National Alliance for Caregiving (NAC), National Association of Area Agencies on Aging (n4a), National Consumers League (NCL), Research!America and the Society for Women’s Health Research. The coalition is sponsored in part by Avanir, Anavex, Biogen Idec, Eli Lilly, Janssen, Merck and Novartis.