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
Published28/02/2018
Effective from01/09/2018
KeywordsAlzheimer’s disease, clinical diagnostic criteria, Alzheimer biomarkers, preclinical Alzheimer disease
Description

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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