Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific guideline

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

Document history - Revision 2

Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease - Revision 2

AdoptedReference Number: CPMP/EWP/553/95 Rev.2Legal effective date: 01/09/2018Summary:

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.

Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias

Draft: consultation closedConsultation dates: 01/02/2016 to 31/07/2016Reference Number: EMA/CHMP/539931/2014Summary:

This guideline replaces 'Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1).

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

AdoptedReference Number: EMA/CHMP/60715/2012Summary:

Despite the rapid progress in understanding of the neurobiology and pathophysiology of Alzheimer’s

disease (AD) only cholinesterase-inhibitors and memantine have been approved for the symptomatic

treatment with overall limited clinical improvement.

Document history - Revision 1

Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1

AdoptedReference Number: CPMP/EWP/553/95 Rev. 1Legal effective date: 01/02/2009

Draft guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1

Draft: consultation closedReference Number: CPMP/EWP/553/95 Rev. 1

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

Reference Number: EMEA/CHMP/EWP/369929/2005

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

Draft: consultation closedConsultation dates: 31/10/2013 to 31/01/2014Reference Number: EMA/CHMP/617734/2013Summary:

The proposed guideline will replace ‘Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1)