Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias

This document aims to provide guidance for the evaluation of any medicinal product for treatment across the AD continuum. In addition, development strategies for disease prevention are addressed. The usefulness of combination therapy targeting multiple pathophysiological mechanisms and their corresponding study designs are discussed.

Dementia is a heterogeneous class of diseases and based on etiologic factors, pattern of impairment, 73 course of dementia and laboratory and imaging tools, distinct subtypes of dementia syndromes are 74 identifiable. Alzheimer´s disease (AD) is the most common cause of dementia, followed by vascular 75 dementias (VaD) or mixed forms of AD and VaD. Other forms of neurodegenerative disorders (e.g. 76 Lewy body disease, frontotemporal dementia) are accompanied with dementia as well. For regulatory 77 purposes high specificity but also high sensitivity of diagnostic criteria will be needed.