EMA: herziene richtlijn over klinische onderzoeken voor geneesmiddelen tegen de ziekte van Alzheimer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a revised guideline on clinical studies for medicines that target Alzheimer’s disease. This document aims to provide guidance for the development of medicines across all stages of Alzheimer’s disease.
Dementia is a key public health priority for EMA. The Agency promoted several initiatives to encourage a broad range of stakeholders to share their experiences and challenges, which were reflected in the revision of the guideline.
EMA’s new guideline addresses, among others:
- impact of new diagnostic criteria for Alzheimer’s disease, including early and even asymptomatic disease stages, on clinical trial design;
- factors to be considered when selecting parameters to measure trial outcomes at the different disease stages in Alzheimer’s;
- potential use of biomarkers in the various stages of medicine development;
- design and analysis of efficacy and safety studies.
The guideline will become effective from 1 September 2018.