Examining the level of test burden in NIA’s Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) clinical trials

Abstract

Background:The National Institute on Aging (NIA) is working to increase access of its AD/ADRD clinical trials (CT) into community health care settings. Concerns exist in the field regarding the feasibility of conducting AD/ADRD CTs outside of academic settings given the testing required within CT protocols. We evaluated recently awarded NIA CTs to document their types and frequency of diagnostic tests required. Findings provide NIA the opportunity to understand the potential test burden on sites and consented participants. Method: We conducted a systematic content analysis of recently funded NIA AD/ADRD CTs involving human subjects to assess the commitment required of participants and the number and type of tests required across protocols (start dates: 2/1/20 -9/30/2021 (N = 115)). Documented tests included: imaging, biospecimen, genetic, sleep, cognitive, and mental health. Findings were analyzed by the CTs' standardized Common Alzheimer's and Related Dementias Research Ontology (CADRO) category. Result: Most CTs (65%) were CADRO C (Translational Research/Clinical Interventions) or E (Dementia Care/Disease Impact; 25%); CADRO E had substantially fewer tests required of participants. Most trials (75%) asked consented participants for less than a year commitment (median = 185 days). Top tests required were cognitive (78% of trials); mental health/well-being (57%); brain imaging (46%; e.g., MRI, PET, MRS), and blood collection (37%). Fewer CTs required lumbar spinal tap (12%). Initial analyses indicate that potentially 75 unique cognitive tests were documented across the 90 CTs assessing cognition, and that participants were asked to complete a median 8.5 cognitive tests per trial (range: 1 to 71 tests).