Recruitment of American Indian and Alaska Native People into Alzheimer’s Disease Clinical Trials

Status: Current

Alzheimer’s disease and related dementias (ADRD) affects 5.5 million Americans. Today, ~200 ADRD trials are seeking more than 270,000 participants, and researchers must screen ~10 people to identify 1 eligible participant. Recruitment of diverse volunteers – by age, race, sex, education, geography, clinical characteristics, and other features – is a formidable challenge, not only in ADRD research, but across most clinical trials. The National Institute on Aging and the Alzheimer’s Association have called for efforts to increase minority participation in clinical trials, but their underrepresentation persists. The lack of participation among American Indian and Alaska Native (AI/AN) people likely results from a confluence of barriers, including their “research readiness,” lack of disease awareness, provider recognition and patient care seeking, and the stigma associated with ADRD. Additionally, many AI/AN communities view research with skepticism and mistrust, in part because research has historically been done on communities rather than with them. Yet, AI/AN people are interested in participating in ADRD clinical trials, and there is growing concern about ADRD among AI/AN people and communities, particularly due to their high prevalence of ADRD risk factors, an aging population, and chronically underfunded healthcare systems.

This project will address recruitment of AI/AN people in ADRD clinical trials. Informed by AI/AN priorities, our established community partnerships, and our prior experience, we will:

  1. Develop a culturally tailored brochure and 4-minute professional video that will encourage AI/AN adults nationwide to participate in a wide range of ADRD clinical trials. We will conduct listening sessions with 32 AI/AN people aged 30 and older recruited both from an existing research registry and online. Participants will provide general advice about how to encourage ADRD clinical trial participation and biospecimen donation. Then, participants will be asked how to adapt existing ADRD and clinical studies recruitment material to encourage AI/AN people to participate in a clinical trial. Session transcripts will be analyzed to develop a brochure and video with identical content.
  2. Conduct a pilot randomized controlled trial (RCT) with a diverse cohort of 120 AI/AN people aged 30 and older recruited online. The trial will compare the effectiveness of the culturally tailored brochure and video. Our primary outcome is enrollment in an AI/AN-focused research registry. This effort will demonstrate the feasibility, acceptability, and generalizability of our recruitment materials. Secondary outcomes are self-reported attitudes about ADRD clinical trials, willingness to participate in ADRD clinical trials and donate biospecimens, and perceptions of the brochure or video. We will use linear regression for continuous outcomes and logistic regression for binary outcomes to evaluate differences in attitudes and willingness.
  3. Create a culturally relevant recruitment framework specific to recruiting AI/AN people into ADRD clinical trials and donating biospecimens. We will review the literature and combine results with information from the listening sessions and the RCT. The framework, findings of the RCT, brochure, and video will be disseminated through our existing network of Satellite Centers – 6 sites led by AI/AN investigators.

Simple, effective interventions that can be rapidly and widely disseminated are critical for increasing AI/AN representation in ADRD clinical trials, including trials where biospecimens are donated. This study promises to efficiently develop and test a simple intervention that, if effective, can be rapidly tailored and disseminated to other populations and settings.

Funding Sponsors

  • University of Southern California Clinical Trial Recruitment Lab

Principal Investigator(s)

Team Member(s)