Disparities by Race and Ethnicity Among Adults Recruited for a Preclinical Alzheimer Disease Trial

Abstract

IMPORTANCE Underrepresentation of many racial/ethnic groups in Alzheimer disease (AD) clinical trials limits generalizability of results and hinders opportunities to examine potential effect modification of candidate treatments.OBJECTIVE To examine racial and ethnic differences in recruitment methods and trial eligibility in a multisite preclinical AD trial. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study analyzed screening data from the Anti-Amyloid in Asymptomatic AD study, collected from April 2014 to December 2017.Participants were categorized into 5 mutually exclusive ethnic/racial groups (ie, Hispanic, Black, White, Asian, and other) using participant self-report. Data were analyzed from May through December 2020 and included 5945 cognitively unimpaired older adults between the ages of 65 and 85 years screened at North American study sites. MAIN OUTCOMES AND MEASURESPrimary outcomes included recruitment sources, study eligibility, and ineligibility reasons. To assess the probability of trial eligibility, regression analyses were performed for the likelihood of being eligible after the first screening visit involving clinical and cognitive assessments. RESULTSScreening data were included for 5945 participants at North American sites (mean [SD] age, 71.7 [4.9] years; 3524 women [59.3%]; 5107 White [85.9%], 323 Black [5.4%], 261 Hispanic [4.4%], 112 Asian [1.9%], and 142 [2.4%] who reported race or ethnicity as other). Recruitment sources differed by race and ethnicity. While White participants were recruited through a variety of sources, site local recruitment efforts resulted in the majority of Black (218 [69.2%]), Hispanic (154 [59.7%]), and Asian (61 [55.5%]) participants. Participants from underrepresented groups had lower mean years of education (eg, mean [SD] years: Hispanic participants, 15.5 [3.2] years vs White participants, 16.7 [2.8] years) and more frequently were women (226 [70.0%] Black participants vs 1364 [58.5%] White participants), were unmarried (184 [56.9%] Black participants vs 1364 [26.7%] White participants), and had nonspousal study partners (237 [73.4%] Black participants vs 2147 [42.0%] White participants). They were more frequently excluded for failure to meet cognitive inclusion criteria (eg, screen failures by specific inclusion criteria: 147 [45.5%] Black participants vs 1338 [26.2%] White participants). Compared with White participants, Black (odds ratio [OR], 0.43;95% CI, 0.34-0.54; P < .001), Hispanic (OR, 0.53; 95% CI, 0.41-0.69; P < .001), and Asian participants (OR, 0.56; 95% CI, 0.38-0.82; P = .003) were less likely to be eligible after screening visit 1.CONCLUSIONS AND RELEVANCE Racial/ethnic groups differed in sources of recruitment, reasons for screen failure, and overall probability of eligibility in a preclinical AD trial. These results highlight (continued) Key Points Question Are there racial/ethnic differences associated with recruitment sources and reasons for ineligibility among preclinical Alzheimer disease clinical trial participants? Findings In th...

Early-stage Alzheimer disease: getting trial-ready

“…Existing registries of individuals with an interest in AD therapeutic research are invaluable sources. A recruitment initiative that has proven to be very effective is the use of national earned media followed by local media featuring local researchers and participants 9 . Another important successful recruitment strategy is the use of local newspapers, including outreach from a ‘trusted’ source.…”

“…Another important successful recruitment strategy is the use of local newspapers, including outreach from a ‘trusted’ source. For example, in the A4 study a letter to the syndicated advice column ‘Dear Abby’ resulted in over 11,000 phone calls, more than 700 referrals to study sites and several hundred screens 9 . The column is run by the daughter of the original Dear Abby, who died from AD.…”

“…AD therapeutic trials in both academic and industry settings have been unsuccessful in recruiting and then enrolling individuals who are representative of the population at risk 9 , 41 . As a consequence, results from AD randomized, controlled trials do not provide adequate data or permit evidence-based assessments of safety and efficacy by race, ethnicity or socioeconomic status.…”

“…The recruitment plan for A4 involved inviting individuals aged 65 years or over for screening with florbetapir amyloid PET scans. As candidates for the study needed to be clinically healthy, memory clinics and other health-care settings were not appropriate sources; instead, outreach efforts focused on earned media coverage 9 , local and national advertising (including social media activities). On the basis of analysis of data from the Alzheimer Disease Neuroimaging Initiative, the A4 study team anticipated that 30% of candidates would have amyloid elevation detected by PET, and this estimate proved accurate.…”

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…Despite an increase in DoC clinical trials over the past decade, access and enrollment remains highly irregular, especially in remote or underserved areas. Racial-, ethnic-, and language-based disparities are also prevalent across a variety of clinical trial domains [ 176 , 177 , 178 , 179 , 180 , 181 ]. Ethical considerations of justice and equity demand close attention to these potential disparities and necessitate strategies to democratize access to DoC clinical-trial enrollment [ 67 , 69 , 70 ].…”