Draft Guideline On The Clinical Investigation Of Medicines For The Treatment Of Alzheimer’’s Disease & Other Dementias

The European Medicines Agency released the draft guidelines in January 2016. The recommendations are focused on clinical trial designs for medications, with specific attention to the impact of new diagnostic criteria, choices of outcome parameters, and potential use of biomarkers. Comments will be accepted through July 31, 2016. The new diagnostic criteria define Alzheimer’'s disease at early and asymptomatic disease stages. Outcome parameters and distinct assessment tools are needed for the different disease stages in for Alzheimer’'s disease. Potential use of biomarkers will differ with the different phases of Alzheimer'’s disease in different stages of drug development . . .