Clinical investigation of medicines for the treatment of Alzheimer's disease
| Current effective version |
|
| Reference number | CPMP/EWP/553/1995 Rev. 2 |
| Published | 28/02/2018 |
| Effective from | 01/09/2018 |
| Keywords | Alzheimer'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 |
| Published: 28/02/2018
Published: 01/02/2016 Published: 31/10/2013 Published: 26/03/2012 |
Revision 1 Current version | In operation: 01/02/2009–present Published: 19/07/2007 Published: 17/11/2005 |
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