The EPAD platform was developed to speed up the development of effective, safe medicines which slow or prevent the development of Alzheimer’s dementia. Although, we were unable to initiate a Proof of Concept Trial, we want to share the EPAD experience on the development of platform trials.
Our trial-ready proof-of-concept (PoC) platform was developed to run Phase II clinical trials with research participants with preclinical and prodromal Alzheimer’s disease, with biomarker evidence of Alzheimer’s disease pathology using a consistent set of outcomes. EPAD was unique in its ability to recruit from the EPAD readiness cohort, guaranteeing recruitment and ensuring a low (10%) screen failure rate.
The platform was open for expressions of interest from pharmaceutical and biotechnology organisations, academic researchers, and funders which had suitable interventions ready for testing.
How Does EPAD Worked?
The platform was designed to efficiently deliver early, accurate results. EPAD studied new drugs in a well-designed Phase II PoC trial with clinical endpoints, utilising the power of adaptive design and Bayesian statistics.
To support this process, we developed three core strategies that offered support and guidance in selecting the optimal trial populations for aspecific compound.
1 The Register
EPAD has created the first single, pan-European register of over half a million people across the risk spectrum for dementia.
2 The Cohort
From this register, participants were invited to join an EPAD cohort, the Longitudinal Cohort Study. This group underwent standardised tests and follow-up over several years.
3 The Trial
EPAD aimed to select suitable participants to take part in streamlined PoC trials of drugs designed to prevent Alzheimer’s dementia.