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European Medicines Agency

EMA revises guidance for medicines development in Alzheimer's disease

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.

The revised guideline will provide guidance on the development of medicines across all stages of the disease and will address the 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 different disease stages; the potential of biomarkers in various stages of medicine development; and the design and analysis of efficacy and safety studies.

The revisions were informed by a workshop for patients, academia, regulators, the pharmaceutical industry and independent experts to ensure that the most up-to-date scientific developments were taken into account.

The EMA then met with developers of medicines to slow disease progression in order to discuss the issues they had encountered in clinical trials.

According to the EMA, currently available medicines for Alzheimer’s disease only treat its symptoms. However, a number of therapies under development are targeting the biological mechanism of the condition to try to modify the course of the disease.

The guideline will come into effect on 1 September 2018.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204495

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