The worldwide COVID-19 pandemic has inevitably impacted EPAD and its sister project AMYPAD.
- EPAD: Most EPAD research and clinical trial activities had to stop as of early March as progressively Universities across Europe closed, and the clinical sites were either closed or saw site staff redeployed to help fight this pandemic. The COVID-19 pandemic has arrived at a time when the team was preparing EPAD for the post-IMI period. The EPAD change management team remains fully engaged in their commitment to execute the sustainability plans. Efforts are underway to redesign the EPAD Longitudinal Cohort Study (LCS) so it can continue at a regional and/or country level. The EPAD team is also focusing on the dataset to assure the existing LCS database and data sharing capabilities. For these reasons, IMI has been engaged to explore the possibility to extend the EPAD project (no-cost extension) beyond its current end date of 30 June 2020 with 4 months until 31 October 2020. In addition, the annual EPAD General Assembly meeting, which was supposed to take place in May in Edinburgh, has been cancelled.
- AMYPAD: Over the past months, the AMYPAD project made good progress with an increase in the recruitment of research participants. However, with the coronavirus spread across European countries, various restrictions have been put in place. This situation adversely affects the AMYPAD project, which has stopped its enrolment of new participants mid-March for both clinical studies, and at this time all recruitment and scan remain on hold. The recruitment of the AMYPAD Diagnostic and Patient Management Study (DPMS) will be able to resume once the situation has stabilised, with an expected delay to reach the 900 participants (initially planned in June 2020). The first data have been collected and the data quality check and clearing is ongoing. The team is focusing on the analysis of available data. The AMYPAD Prognostic and Natural History Study (PNHS) has also been placed on hold and all sites have stopped their recruitment until further notice. Another challenge within the last month has been the early closure of EPAD LCS. Sites are now focusing on submission of a protocol amendment to Ethics Committees and Regulatory Authorities in order to allow for retention of EPAD participants post-EPAD closure, as well as for enabling and the follow-up of these participants within AMYPAD instead of EPAD moving forward. At the same time, numerous activities are ongoing related to the collection and integration of data for analysis purposes.
“All participants from our observational studies, like EPAD, AMYPAD, ALFA+ study, etc., and trials, PENSA, AB1601, are not allowed, by law, to come in, hence from a safety perspective we are on good grounds. We are aware of the impact on our studies, so we are working hard adapting them with the necessary protocol amendments to ensure their viability and validity after the crisis. Our IT teams are working on existing data to clean it and make it accessible to our research team, who is focusing on analysis and writing results from their homes”, says Dr José Luis Molinuevo, scientific director of the Alzheimer’s Prevention Program at BBRC.