The FDA has proposed changes to its approval process for new Alzheimer’s drugs, which is expected to ease approval by providing clearer criteria. Published on the website of The New England Journal of Medicine, the plan would eliminate the requirement that a clinical trial show improvement in patients’ daily functioning. Rather, improvement in early-stage Alzheimer’s patients would now be measured using cognitive tests. Post-approval studies would also be required. Observers expect the changes to lead to more clinical trials for such drugs. Studies currently planned for drugs to treat early-stage Alzheimer’s or persons with indications of developing Alzheimer’s include studies by the NIH, Eli Lilly & Company, and Genentech.

Source: The New York Times