New Online Tool Aims to Increase Participation, Diversity in Dementia Trials

New Online Tool Aims to Increase Participation, Diversity in Dementia Trials
Home caregiver and senior woman holding hands

A new online tool to help researchers and clinicians increase awareness and participation in clinical trials on Alzheimer’s disease and other dementias has been launched. One key goal with Outreach Pro is to increase participation among traditionally underrepresented communities.

“There is a well-recognized need for diversity in clinical trial populations to ensure diagnostics and treatments are safe and effective for everyone,” said Carl V. Hill, Ph.D., Alzheimer’s Association chief diversity, equity and inclusion officer. “It’s imperative that the Alzheimer’s community is aware of the impact of historical racism, and also the current racial discrimination in health care that presents obstacles for inclusive participation in Alzheimer’s trials..”

Using NIA’s Outreach Pro, researchers and clinicians can make outreach materials from templates designed to: Educate people about Alzheimer’s and dementia, increase overall awareness of Alzheimer’s clinical trials, and provide information about a specific Alzheimer’s or dementia clinical study open to recruitment.

Each template can be tailored using a central library of messages, headlines, photos and text that have been extensively tested with individuals, including those representing diverse and underserved populations.

Outreach Pro’s current library of content includes materials designed specifically for African American and Hispanic/Latino populations and is available in English and Spanish. Plans are underway to add materials developed for Asian Americans and Pacific Islanders in multiple languages by Fall 2021, and materials for American Indian and Alaska Native communities to be developed and added in 2022.

The release of Outreach Pro was announced at the Alzheimer’s Association International Conference (AAIC) in Denver. Other key findings presented at the meeting included:

  • Individuals are most willing to volunteer for a clinical trial if they are invited to participate (85%), want to contribute to the goal of research (83%) or have a family member with the disease (74%).
  • African American, Latino and American Indian respondents are significantly more likely to volunteer if asked by a person of the same race, and are more concerned than Whites about disruption of work and family responsibilities and availability of transportation and childcare.
  • Commonly used Alzheimer’s clinical trial exclusion criteria have the potential to disproportionately affect African Americans and Hispanics/Latinos, which may play a role in their reduced enrollment in research.

In this last report, Alexandra Mitchell, Clinical Research Coordinator at NIA, Holly Massett, PhD, NIA Senior Advisor on Clinical Research Recruitment and Engagement, and colleagues conducted a content analysis of 235 active NIA-funded Alzheimer’s and dementia clinical trials to identify the most widely used criteria and their potential to disproportionately exclude African Americans and Hispanics/Latinos from the research.

They identified 2,761 exclusion criteria and grouped them into 56 categories. On average, each trial had 11.75 exclusion criteria, with drug trials having the highest (18.14 per trial). Not surprisingly, “dementia/cognitive impairment” was the most common category (identified in 49% of trials). The researchers found that 142 trials (60%) had at least one exclusion category that could disproportionately affect African American or Hispanic/Latino populations.

“This analysis is helping us ask an important question: Can we strengthen our criteria for clinical trials to maximize the number of eligible people from diverse and under-represented communities?” Mitchell said.

The Alzheimer’s Association is leading two major clinical trials with a strong focus on diverse participation. The New IDEAS study is recruiting 2,000 Latinos and 2,000 African Americans to investigate the impact of a brain amyloid PET scan on clinical care outcomes, including diagnosis and treatment. The US Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (US POINTER) study is a two-year clinical trial studying the effects of multi-component lifestyle interventions on risk of cognitive decline in a diverse population in the US.