AMYPAD members restart trial recruitment and continue to work on data analysis

26/08/2020

In its August newsletter, the Amyloid imaging to prevent Alzheimer’s disease (AMYPAD) project reported that both of its studies have been impacted by the COVID-19 pandemic.

  • AMYPAD Diagnostic and Patient Management Study (DPMS): The COVID-19 pandemic has impacted recruitment of new participants (9 participants in Q2 2020 vs 118 in Q1 2020). The recruitment period between January and February 2020 was very productive. However, from March the AMYPAD team has observed a drastic decrease in the recruitment of patients in all eight active sites due to the COVID-19 pandemic. Recruitment stopped in all sites from the second week of March to the end of April. Starting from May, recruitment has slowly restarted in some countries. As of August 24th, 2020, 780 participants have been included and 616 scans performed (including 26 repeated scans). The recruitment will be able to resume in all eight sites once the situation has stabilised, with an expected delay to reach the 900 target.

  • AMYPAD Prognostic and Natural History Study (PNHS): Recruitment activity within the AMYPAD PNHS had also stopped during the COVID-19 crisis. This was due to the closure of sites and cessation of research visits. Consequently, the past months have seen slow progress within the PNHS in terms of recruitment. By June 2020 some AMYPAD PNHS sites had slowly started to resume recruitment, always taking into account local and national measures concerning safety and distancing. Of the 17 active sites in the PNHS, 12 sites have been able to resume recruitment, although at reduced capacity. It was expected that all sites could restart their activities in September; however, the current developments with COVID-19 could cause another period of site closures and slow activity. Despite the difficulties, the PNHS has now reached 600 subjects consented, coming from six different Parent Cohorts.

Despite the recent low recruitment into both studies, the AMYPAD teams have continued to analyse images from external cohorts as well as starting to analyse images from both AMYPAD studies. The team was also excited to be chosen for a ‘Featured Research Session’ at the virtual Alzheimer’s Association International Conference (AAIC) in July with a topic covering ‘The value of amyloid PET beyond dichotomization’ and presentations from Isadora Lopes Alves, Lyduine Collij, Santi Bullich and Jose Luis Molinuevo. Over the coming months, the consortium is planning its annual General Assembly meeting as it enters into its fifth and final year of AMYPAD so the discussions will be focusing on analysis plans, pivotal publications and completing final milestones as well as addressing topics such as data access and sustainability.

The AMYPAD project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. The Joint Undertaking receives support from the European Union’s Horizon2020 research and innovation programme and EFPIA.