Recruitment activity within the AMYPAD Prognostic and Natural History Study (PNHS) had stopped during the last quarter. This was due to the closure of sites and cessation of research visits as a result of the global COVID-19 crisis. During this time, sites were able to focus on other study related activities such as the backlog of data entry, quantification and preparation of documents needed for the global amendment.
By June 2020 some AMYPAD PNHS sites had slowly started to resume recruitment. There are currently 17 active sites in the PNHS. 9/17 sites have begun to resume recruitment. These sites are carefully taking into account local and national measures concerning safety and distancing and it is expected that all sites will follow suit by September 2020.
Consequently, the past quarter has seen little progress within the PNHS in terms of recruitment due to the COVID-19 crisis. By the end of June 2020, 890 participants have been informed about the study, 579 consented, and 421 already underwent their amyloid PET scan. Moving forward, PNHS sites will focus on submission of the global amendment to Ethics Committees and Regulatory Authorities in order to allow for the continued recruitment and follow-up of former EPAD LCS participants and undergo the training required for the collection of additional data and for the use of the eCRF database designed for the non-EPAD Parent Cohorts.