Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific guideline

This guideline provides guidance for the development of medicines across all stages of Alzheimer's disease. It covers the impact of new diagnostic criteria for Alzheimer's, including early and even asymptomatic disease stages, factors to be considered when selecting parameters to measure clinical trial outcomes at the different disease stages in Alzheimer's, the potential use of biomarkers in the various stages of medicine development and the design and analysis of efficacy and safety studies.

Keywords: Alzheimer's disease, clinical diagnostic criteria, Alzheimer biomarkers, preclinical Alzheimer disease