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.
AMYPAD Diagnostic and Patient Management Study (DPMS):
During the last quarter, the recruitment of participants has been high across the eight European sites. This positive trend was recently followed by another positive news. Indeed, January 2020 was the best month for recruitment ever, with 62 participants enrolled. At the moment, 754 participants have been included. Scanning activities have also progressed along with the recruitment of new participants with a total of 542 scans performed. Unfortunately, the rise of the COVID-19 pandemic has put the study on hold as of March 11th for an unknown duration. The recruitment 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 preliminary results (participants’ baseline features) were presented by Daniele Altomare (UNIGE) at the virtual AAT-AD/PD™ Focus Meeting (April 2020).
AMYPAD Prognostic and Natural History Study (PNHS):
The past quarter has also seen good progress in the PNHS, with the activation of all 17 planned sites and passing the 500 milestone with the number of consented participants by mid-February. This period also saw an increase in the number of active cohorts. There are currently five cohorts active in AMYPAD PNHS, namely EPAD LCS, EMIF-AD, ALFA+, FPACK and FACEHBI. At least two additional cohorts are planned to start once activities resume. The PNHS has consented a total of 572 participants, of which 405 have been scanned.
The study has now been placed on hold due to the COVID-19 pandemic 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 historical data from these cohorts for analysis purposes.
