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 |
Related content
- Directive 2001/83/EC
- Choice of a non-inferiority margin
- Clinical evaluation of new vaccines
- Clinical investigation of medicinal products in the treatment of Parkinson's disease
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E7 Studies in support of special populations: geriatrics
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Investigation of drug interactions
- Missing data in confirmatory clinical trials
- Pharmacokinetic studies in man