Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific guideline
Table of contents
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
-
List item
Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease - Revision 2 (PDF/456.32 KB)
Adopted
First published: 28/02/2018
Last updated: 28/02/2018
Legal effective date: 01/09/2018
CPMP/EWP/553/95 Rev.2 -
List item
Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias (PDF/418.57 KB)
Draft: consultation closed
First published: 01/02/2016
Last updated: 01/02/2016
Consultation dates: 01/02/2016 to 31/07/2016
EMA/CHMP/539931/2014 -
List item
Concept paper on no need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 2 (PDF/147.23 KB)
Adopted
First published: 26/03/2012
Last updated: 26/03/2012
EMA/CHMP/60715/2012
-
List item
Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1 (PDF/140.16 KB)
Adopted
First published: 24/07/2008
Last updated: 24/07/2008
Legal effective date: 01/02/2009
CPMP/EWP/553/95 Rev. 1 -
List item
Draft guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1 (PDF/120.32 KB)
Draft: consultation closed
First published: 19/07/2007
Last updated: 19/07/2007
CPMP/EWP/553/95 Rev. 1 -
List item
Recommendation on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Alzheimer's disease (CPMP/EWP/553/95) - Revision 1 (PDF/32.62 KB)
First published: 17/11/2005
Last updated: 17/11/2005
EMEA/CHMP/EWP/369929/2005 -
List item
Draft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1 (PDF/128.98 KB)
Draft: consultation closed
First published: 31/10/2013
Last updated: 31/10/2013
Consultation dates: 31/10/2013 to 31/01/2014
EMA/CHMP/617734/2013