The lack of definitive biological markers for the earliest stages of Alzheimer’s disease has made it impossible to enroll patients in drug-research trials, U.S. regulators said, slowing development of new treatments.
The methods for trials were established in 1984 and cover patients with full-blown dementia who suffer both cognitive and functional limitations, the Food and Drug Administration said in a statement today. The agency is proposing to relax guidelines for early-stage Alzheimer’s drug trials by letting researchers show that a medication slows the cognitive decline, rather than improvement in both cognitive and functional deterioration.
People in the earliest stages of Alzheimer’s don’t always have functional limitations such as problems getting dressed, bathing and taking care of their own daily needs. For this group of people, showing that a medication slows the cognitive decline may be enough to win regulatory approval, the FDA said.
After an approval, companies would have to conduct larger, longer studies to show the improvement in mental function translates into improved health, the FDA said.
The draft document is subject to a 60-day comment period and could change based upon the input the FDA receives.