Redesigning Clinical Trials in Alzheimer Disease to Promote Diversity and Accessibility

Jessica Langbaum, PhD

(Credit: Banner Health)

Alzheimer disease (AD) affects millions worldwide, presenting immense challenges for patients, families, and healthcare systems. Despite decades of research, the need for more effective treatments and preventive strategies remains urgent. Clinical trials play a pivotal role in advancing the understanding of AD, yet these studies face persistent issues, particularly in recruiting diverse populations reflective of the broader community who are impacted by this disease.

Diversity in clinical trials is crucial to ensuring treatments are effective across all different patient populations. Historically, AD trials have disproportionately enrolled highly educated, nonHispanic White participants, leaving underrepresented groups, including minorities, rural populations, and those with lower socioeconomic status, excluded. These disparities hinder the development of broadly applicable therapies and ignore the unique risks and outcomes experienced by different communities. Addressing these gaps requires rethinking trial design, recruitment strategies, and outreach efforts to create equitable access for all.

At the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain, attendee Jessica Langbaum, PhD, senior director of research strategy at Banner Alzheimer’s Institute, shared her insights into the barriers and opportunities in recruiting diverse populations for AD clinical trials. In an interview with NeurologyLive^®, she highlighted innovative approaches that aim to make trials more accessible and inclusive. These strategies, combined with a focus on addressing systemic inequities, may hold promise for advancing Alzheimer research and ensuring treatments benefit all communities.

NeurologyLive: How can we improve recruitment strategies for minority patient populations in AD, address trial design barriers, and ensure transparent risk disclosure?

Jessica Langbaum, PhD: Recruitment of individuals from diverse, underrepresented backgrounds in clinical trials is incredibly important. Unfortunately, as a field, we’ve done a poor job of this so far. Trial after trial, if you look at the enrollment data, it’s predominantly highly educated, nonHispanic White individuals.

The question is: Why? People from underrepresented backgrounds are certainly interested in participating in trials, but they’re not always invited. So, part of the solution is asking patients to participate in clinical trials, offering those opportunities, and creating recruitment and outreach materials that address their concerns, needs, and priorities.

Beyond simply asking, we need to design trials that are accessible. For example, many studies require participants to have a study partner—someone close to them who can attend study visits. That’s a big barrier. Study visits often take place Monday through Friday, 9 a.m. to 5 p.m., when study partners may be working or caring for children. Additionally, participants may be required to travel long distances or navigate complex medical centers for parking. Often, ground transportation isn’t even provided.

As a clinical trial ecosystem, we must do better. One promising area is decentralized trials. While I’m not sure where the term originated, it essentially means allowing participants to complete many study procedures from home or at accessible community centers rather than traveling to large academic medical centers. This approach can not only increase racial and ethnic diversity but also include diversity in socioeconomic status, education, and geographic location.

A good example is the TRAILBLAZER-ALZ-3 study (NCT05026866), a decentralized trial where the study partner can live in an entirely different city from the participant. Assessments are done online, and tablets are provided by the study sponsor. Participants and their study partners don’t need to complete assessments simultaneously, allowing flexibility for evenings or weekends. This approach improves accessibility while maintaining the integrity of the study.

Another issue is ensuring participants are supported once they express interest. While some studies have made progress in screening diverse populations, many participants from underrepresented groups fail screening because of biomarker eligibility criteria. As a field, we need to understand why these individuals aren’t meeting the criteria at the same rate as their nonHispanic White counterparts and address this disparity.

Is there anything else you think should be emphasized regarding clinical trial recruitment?

I’m excited about the progress we’re making in evidence-based recruitment messaging. Outreach materials are an area of focus for me—how do we create messaging that is welcoming and meaningful to different groups? This includes using imagery and language that resonates with diverse populations.

There’s a real science to recruitment outreach that we’ve overlooked. Too often, we rely on glossy campaigns that look good but aren’t tested for effectiveness. This is an opportunity to apply clinical trial methodology to outreach—working with communication scientists to develop campaigns that motivate people and encourage participation. Of course, these campaigns must also be paired with trials that are welcoming, inviting, and accessible.

Over time, do you think making trials more accessible, even from home, will improve participation in AD studies?

Absolutely. It’s also about understanding patients’ first points of contact within the healthcare system—often their primary care doctors. Primary care physicians are overwhelmed, but we could use electronic health records (EHR) to flag potential trials for eligible patients.

Patients often want their primary care doctor’s approval or support before enrolling in a trial. For those who have a primary care doctor, receiving a supportive message about a trial—like, “This study might be worth exploring”—can be very influential.

These are ideas we’re actively testing. My colleagues and I have an NIH-funded R01 grant focused on accelerating the enrollment of individuals from underserved backgrounds into clinical trials. We’re using communication science principles to explore platforms that streamline recruitment. People want to participate; we just need to ensure they have the opportunity.

Transcript edited for clarity. Click here for more coverage of CTAD 2024.