Clinical investigation of medicines for the treatment of Alzheimer's disease

Current effective version

PDF iconRevision 2 - Adopted guideline

Revision 2 enters into effect 01/09/2018 - see below

Reference numberCPMP/EWP/553/1995 Rev. 2
Effective from01/09/2018
KeywordsAlzheimer's disease, clinical diagnostic criteria, Alzheimer biomarkers, preclinical Alzheimer disease

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.

Document history

Revision 2

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper


PDF iconConcept paper

Published: 28/02/2018
Effective from: 01/09/2018


Published: 01/02/2016


Published: 31/10/2013


Published: 26/03/2012

Revision 1

Current version

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/02/2009–present


Published: 19/07/2007


Published: 17/11/2005

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