Alliance’s ACT-AD, Leading Organizations Share Feedback on Alzheimer’s Research
Published June 10, 2024
The Alliance, via the ACT-AD initiative, and eight other leading organizations submitted comment to the U.S. Food and Drug Administration (FDA) regarding their proposed guidance on “Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability.” The comment letter supports the FDA’s efforts to provide additional clarity around the development of drugs for early stages of Alzheimer’s disease in research and in clinical trials, while requesting several areas of clarification, including:
- Recommending that the FDA include Stage 4 of Alzheimer’s disease in the scope of this guidance, given that individuals often express characteristics of different stages concurrently,
- Validation of biomarkers that can help confirm the presence or absence of the disease, and
- The accuracy of clinical trial endpoints across diverse populations.
The letter also voices support for application of time-to-event analyses, which can help measure how an intervention can delay the progression of disease, as an indicator of efficacy in clinical trials for early Alzheimer’s disease.
The following organizations joined the letter:
- Alliance for Aging Research
- LEAD Coalition
- American Academy of Neurology
- American Association for Geriatric Psychiatry
- Global Alzheimer’s Platform Foundation
- National Minority Quality Forum
- Partnership to Fight Chronic Disease
- UsAgainstAlzheimer’s
- Voices of Alzheimer’s