Clinical Meaningfulness in Drug Development for Early Alzheimer’s Disease
An FDA/Alzheimer’s Disease Allies Meeting
Thursday, November 6, 2014
7:30 AM – 2:00 PM
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road, Bethesda, MD 20852
In 2012 the FDA published a draft guidance for industry on therapeutic development for early Alzheimer’s disease. This draft guidance provides an overview of the Agency’s thinking on requirements for demonstrating clinical meaningfulness in clinical trials of earlier stage Alzheimer’s patients. This meeting will explore challenges related to the current means of measuring clinical meaningfulness at earlier stages of Alzheimer’s disease, including mild Alzheimer’s dementia. Participants will discuss how to balance the needs of all stakeholders in the drug development process who seek more effective treatments and will begin to forge agreement on current strategies for demonstrating clinical meaningfulness in existing trials of early patients and how they might inform approaches for future trials.
The meeting agenda is available online. Breakfast and lunch will be served. A limited number of guest rooms are available at the reduced rate of $223/ night at the Bethesda North Marriott Hotel & Conference Center. Please contact Sarah DiGiovine about reserving a room.
For more information about this event, email Cynthia Bens.