FDA Revises Alzheimer’s Trial Guidelines to Help Researchers Focus on Early Disease Stages

FDA Revises Alzheimer’s Trial Guidelines to Help Researchers Focus on Early Disease Stages
The U.S. Food and Drug Administration has revised clinical trial guidelines for Alzheimer's therapies to help researchers come up with trial objectives that are better suited to patients in the early stages of the disease. European regulators have also revised their Alzheimer's trial guidelines. The early-stage patients that the new FDA guidelines are intended to help include people who have yet to display memory loss or functional impairment. Both the new FDA and European Medicines Agency (EMA) guidelines reflect many researchers’ goal of developing therapies for early Alzheimer’s, following continued failures in drug development for this disease. U.S. regulatory documents cover a broad range of subjects, including how to develop new treatments and how to prepare submissions for a combination product — one composed of any combination of a drug and a device. The new guidance is a revision of a 2013 draft. It addresses FDA’s current thinking on the selection of patients in the early stages of a disease for clinical trials, diagnostic criteria for asymptomatic patients, trial outcome measures, and the selection of endpoints. In one section,
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