Trial readiness amongst EPAD longitudinal cohort study participants: Insights from the SPEAR study

Background SPEAR (Study of Participant Experience of Alzheimer’s disease Research) was a sub‐study of work on the Ethical, Legal and Social Implications of the European Prevention of Alzheimer’s Dementia (EPAD) project. The EPAD Longitudinal Cohort Study (LCS) aimed to generate a detailed picture of biological and cognitive change over time, and to build a ‘readiness cohort’ to recruit eligible and willing participants into clinical trials. This poster presents findings about the willingness of cohort participants to participate in a future clinical trial. Method A mixed‐method study was conducted with members of the EPAD Longitudinal Cohort Study (LCS) to explore motivations to participate, study experience and likely future participation in an Alzheimer’s prevention trial. A questionnaire was completed by 101 participants and 7 study partners from 4 EPAD sites across the UK. In‐depth qualitative interviews were conducted with 25 EPAD participants and study visits observed from the same 4 sites. Result Over half of participants would consider participating in a clinical trial at the time of data collection. Almost none reported that they would “never” participate. The timing, location and duration of trials were important in how likely they would be to participate. The qualitative findings revealed a range of tentative attitudes towards the prospect of being recruited to a clinical trial, including feeling “morally obliged to continue” or indicating “I don’t want a drug,” should they agree to participate. Some said changes in their memory or cognition may also influence future decisions. Conclusion Whilst we saw high levels of willingness to participate in a clinical trial, these data highlight the importance of understanding how motivations, willingness, and expectations for trial participation may change over time. This supports the use of a staged consent model such as that adopted by EPAD. Qualitative research is needed to understand underlying reasons for participants’ trial readiness to identify any ethical issues in the recruitment of future trial participants.