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

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Current effective version

Revision 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


Adopted guideline


Draft guideline


Concept paper

Concept 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

Adopted guideline

Draft guideline

Concept paper

In operation: 01/02/2009–present

Published: 19/07/2007

Published: 17/11/2005

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