Guidance on Late-phase Clinical Studies to Evaluate Pharmacologic Therapies in Alzheimer's Disease
Building on a 2013 GPC guidance document, this initiative will provide updated guidance on methods for evaluating the efficacy of therapies to treat Alzheimer's disease.
The field of Alzheimer’s therapeutics has rapidly progressed over the past few years to focus increasingly on earlier stages of disease and on disease interception. This new focus raises issues regarding the types of evidence needed by health plan decision-makers to cover these new therapies. How can study designers assure that patients are correctly identified as candidates for therapy? How long should patients be followed to demonstrate benefit?