Recruiting to preclinical Alzheimer's disease clinical trials through registries

Abstract

Participant registries are repositories of individuals who have expressed willingness to learn about studies for which they may be eligible. Registries are increasingly being used to improve recruitment to preclinical Alzheimer's disease (AD) clinical trials, which require large screening efforts to identify adequate numbers of participants who meet enrollment criteria. Recruiting to preclinical AD trials from registries is made more efficient through registry collection of data that permits exclusion of those who will not be eligible and identifies individuals most likely to qualify for trials. Such data could include self-reported disease family history or other risk factors but could also include cognitive, genetic, or biomarker testing outcomes. Few data are available to guide investigators overseeing registries and important ethical questions are likely to arise related to their conduct, especially in registries collecting AD risk information. This article outlines three areas of consideration for registry investigators: informed consent, disclosure, and sponsorship.

Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings

“…Clinical trial screening of these mildly symptomatic or asymptomatic participants is accompanied by large numbers of screen failures [1]. The solution may be to introduce low-burden prescreening steps, which would limit the screening efforts to individuals with an increased prospect of enrolment into the study [4][5][6][7]. However, there is little empirical evidence on prescreening for secondary prevention trials and whether the efficacy depends on recruitment setting [8][9][10][11].…”

Using a birth cohort to study brain health and preclinical dementia: recruitment and participation rates in Insight 46

“…There is growing interest in recruiting people with early pre-symptomatic Alzheimer’s disease (AD) into neuroimaging studies [ 1 ]. Successful recruitment of older adults into dementia studies is notably challenging [ 2 – 4 ]; efforts are being made to create registers and “ready-made” cohorts, which includes embedding sub-studies within existing longitudinal studies [ 5 – 7 ]. To plan relevant studies, and interpret whether results are generalisable, it is important to understand factors that influence recruitment and retention [ 8 , 9 ].…”

Patient Engagement: The Fundació ACE Framework for Improving Recruitment and Retention in Alzheimer’s Disease Research

“…The expansion and coordination of existing participant registries has been proposed as a method to increase enrollment [ 11 ]. However this remains a challenging task as registries can differ in scale (multinational: European Prevention of Alzheimer’s Consortium [EPAD], Global Alzheimer’s Platform [GAP]; national: Alzheimer’s Prevention Registry, Alzheimer Association’s TrialMatch; local institute-specific registries at academic and research centers), model (disease-specific versus general recruitment), and type of data contained (contact information, medical data) and little research is available for guidance [ 36 ]. Besides increasing the quantity and speed of recruitment, recently started multinational initiatives such as EPAD and GAP will play a major role in increasing sustainability of AD research.…”

“…Adding positive biomarkers to inclusion criteria also complicates recruitment. Biomarker analysis is not part of the typical work up in cognitively intact subjects and predicting a positive result based on clinical evaluation is very challenging which can lead to high screen failure rate due to biomarker negativity [ 36 ].…”