|Contact||Professor Craig Ritchie, UK National Lead, Centre for Clinical Brain Sciences, University of Edinburgh|
The European Prevention of Alzheimer’s Dementia (EPAD) project (www.ep-ad.org) is aimed at creating a platform for faster and better assessment of drugs for the prevention of Alzheimer’s dementia in people at risk of developing the disease, but with no or mild symptoms. This includes evaluating patients’ reactions to a drug early in a clinical trial and modifying the trial according to these reactions.
A consortium of 35 academic institutions, pharmaceutical companies, SMEs and patient organisations have joined forces to develop this ambitious project, funded under the auspices of the Innovative Medicines Initiative (www.imi.europa.eu) programme. The EPAD project will initially run for five years.
The platform will draw European participants, whose records are already part of existing national/regional cohort or register studies, into an EPAD register of approximately 24,000 people. From this group, 6,000 people will be asked to join a pan-European EPAD Cohort for consistent, longitudinal follow-up, and approximately 1,500 of them will eventually be invited to enter the standing EPAD Proof of Concept Trial. This approach aims to ensure EPAD has access to an at-risk population showing biomarker evidence of Alzheimer’s disease prior to the development of dementia.
All data collected from the cohort and trial will become publically available for analysis to improve disease models in the pre-dementia phase of Alzheimers’ disease. This should lead to more accurate stratification for trial selection, improved measurements of outcomes and a greater understanding of Alzheimer’s disease processes before dementia develops.
This project has numerous advantages over current approaches, including:
- excellent pre-trial characterisation of subjects to inform selection and reduce screen failure
- establishment of the highest possible quality Trial Delivery Centres (TDC’s) across Europe, and
- rapid decision making on the likely success of a drug (or combination of drugs) in subsequent confirmatory trials and access to a shared placebo group.