New online tool launched to increase awareness and participation in Alzheimer's clinical trials

New online tool launched to increase awareness and participation in Alzheimer's clinical trials

Also at AAIC 2021, the National Institute on Aging (NIA), part of the US National Institutes of Health, launched a new online tool, Outreach Pro, to help researchers and clinicians increase awareness and participation in clinical trials for Alzheimer's disease and other dementias, particularly among traditionally underrepresented communities.

There is a recognized need for diversity in clinical trial populations to ensure that diagnoses and treatments are safe and effective for all. It is imperative that the Alzheimer's community be aware of the impact of historical racism, as well as current racial discrimination in healthcare, which presents barriers to inclusive participation in Alzheimer's disease trials. And equally important, we evaluate strategies that have proven effective in recruiting historically underrepresented individuals and communities into these important Alzheimer's disease research studies.”

Carl V. Hill, MPH, Ph.D., Chief Diversity, Equity and Inclusion Officer of the Alzheimer’s Association

Other key results first reported at AAIC 2021 include:

• Personen sind am ehesten bereit, sich freiwillig für eine klinische Studie zu melden, wenn sie zur Teilnahme eingeladen werden (85 %), zum Forschungsziel beitragen wollen (83 %) oder ein Familienmitglied mit der Krankheit haben (74 %).
• Befragte aus Afroamerikanern, Latinos und Indianern melden sich mit signifikant höherer Wahrscheinlichkeit freiwillig, wenn sie von einer Person derselben Rasse gefragt werden, und sind besorgter als Weiße über die Beeinträchtigung der Arbeit und der familiären Pflichten sowie die Verfügbarkeit von Transportmöglichkeiten und Kinderbetreuung.
• Häufig verwendete Ausschlusskriterien für klinische Alzheimer-Studien haben das Potenzial, Afroamerikaner und Hispanics/Latinos überproportional zu beeinflussen, was eine Rolle bei ihrer geringeren Teilnahme an der Forschung spielen könnte.

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

NIA Launches Alzheimer's Research Recruitment Materials for Underrepresented Communities

NIA has launched a new online tool to increase awareness and participation in clinical trials for Alzheimer's disease and related dementias. The tool, called Outreach Pro (V1.0), enables researchers, clinicians, clinical trial administrators and staff to create and customize outreach materials such as websites, handouts, videos and social media posts, with a focus on reaching traditionally underrepresented communities.

NIA's Outreach Pro allows researchers and clinicians to create outreach materials from templates designed to:

1. Informieren Sie die Menschen über Alzheimer und Demenz.
2. Steigerung des allgemeinen Bewusstseins für klinische Alzheimer-Studien.
3. Bereitstellung von Informationen über eine spezifische klinische Studie zu Alzheimer oder Demenz, die für die Rekrutierung offen ist.

Each template can then be customized using a central library of news, headlines, photos and text that has been tested extensively with individuals, including those representing diverse and underserved populations.

The development of Outreach Pro is an integral part of NIA's efforts to implement the national strategy for recruitment and participation in clinical research on Alzheimer's disease and related dementias. The national strategy, published in 2018, was developed with the support of the Alzheimer's Association, with the aim of engaging broad segments of the public in Alzheimer's and dementia research, with a particular focus on underrepresented communities.

“It is critical that clinical trials are adequately represented to ensure we have a complete understanding of how well different therapies or approaches to dementia care work in different populations,” said Holly Massett, Ph.D., senior advisor on clinical research recruitment and engagement at NIA, who oversees implementation of the national strategy. “Outreach Pro is designed to provide well-tested and culturally appropriate educational materials that resonate with diverse populations and encourage them to participate in clinical trials.”

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Outreach Pro's current content library includes materials specifically designed for African American and Hispanic/Latino populations, available in English and Spanish. Materials developed for Asian Americans and Pacific Islanders are planned to be added in multiple languages ​​by fall 2021, and materials for American Indian and Alaska Native communities are planned to be developed and added in 2022.

People are more likely to participate in clinical trials if they are invited by someone of the same race

Dorothy Farrar Edwards, Ph.D., faculty director of the University of Wisconsin Collaborative Center for Health Equity and investigator and Outreach, Recruitment and Engagement Core Leader for the Wisconsin Alzheimer's Disease Research Center, and colleagues created the Voices Heard Survey to examine associated factors to identify with willingness to participate in biomedical research. The survey was conducted on a diverse sample of 406 Wisconsin residents, including White (n=100), African American (n=105), Latino (n=100), and Native American (n=101) adults. The 96-item survey assessed trust in medical research and identified factors that positively or negatively impact willingness to participate in biomedical studies and clinical trials.

The factors most strongly associated with willingness to volunteer for a study across the group were (1) invitation to participate (85%), (2) research goal (83%), and (3) family member with illness (74%).

Significant differences were observed between the white and minority groups. Specifically, African American, Latino, and Native American respondents are significantly more likely to volunteer for a research study when asked by a person of the same race, and are more concerned than whites about interference with work and family responsibilities, the availability of transportation, and child care.

“We identified opportunities for tailored messaging aimed at raising awareness of the value of participating in Alzheimer’s research,” said Farrar Edwards. “As we get better at recruiting diverse populations, it will increase the urgency of getting trials done right.”

Do common exclusion criteria in Alzheimer's clinical trials exclude underrepresented groups?

In a first systematic look at commonly used exclusion criteria in active NIA-funded clinical trials for Alzheimer's disease and related dementias, NIA researchers note that many criteria have the potential to inadvertently exclude African American and Hispanic/Latino participants. This new study, reported at AAIC 2021, suggests that a closer, collaborative look at the criteria could improve enrollment. Eligibility criteria are integral parts of clinical trials that help ensure the safety of participants and reduce factors that can confound results.

Alexandra Mitchell, Clinical Research Coordinator at NIA, Holly Massett, Ph.D., 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 commonly used criteria and their potential, Disproportionately exclude African Americans and Hispanics/Latinos from research. They identified 2,761 exclusion criteria and grouped them into 56 categories. On average, each study had 11.75 exclusion criteria, with drug studies having the highest (18.14 per study). Not surprisingly, “dementia/cognitive impairment” was the most common category (identified in 49% of studies). However, the next three most common categories included medical, neurological, and psychiatric criteria that were deemed “broadly defined,” so they could introduce an unintended level of subjectivity when investigators determine eligibility. Additionally, researchers found that 142 studies (60%) had at least one exclusion category that could disproportionately affect African American or Hispanic/Latino populations.

“This analysis helps us ask an important question: Can we strengthen our clinical trial criteria to maximize the number of eligible individuals from diverse and underrepresented communities?” Mitchel said. “We hope the Alzheimer's community will take a closer look and emulate the success in oncology, where a concerted effort resulted in reformulated, fairer exclusion criteria.”

Source:

Alzheimer's Society

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