Leaders of the U.S. POINTER Study announced a historic milestone this month: recruiting for the national clinical trial, which focuses on maintaining brain health in aging adults, has been completed. More than 2,000 volunteers are enrolled across five study sites, including 376 volunteers at a study site based in Rhode Island Butler Hospital’s Memory and Aging Program (MAP).
U.S. POINTER Study Explained
The Alzheimer's Association U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a two-year clinical trial to evaluate whether lifestyle interventions targeting many risk factors can protect cognitive function in older adults at increased risk for cognitive decline. Results from the ongoing study are expected to be available in 2025.
U.S. POINTER is the first such study on a large, diverse group of Americans across the United States. It will collect essential data, including information about participants’ genetics, brain imaging, microbiome, neurovascular systems, and sleep. It will also study whether changing to a healthier diet and more active lifestyle can help protect memory and thinking in adults as they age.
The study is also part of the Alzheimer’s Association’s “World-Wide FINGERS” (WW-FINGERS) initiative, an interdisciplinary network through which researchers from 35 countries across six continents collaborate to harmonize data and plan joint international initiatives to reduce the risk of cognitive impairment or dementia.
Rhode Island’s Participation and Important Role
The Providence site is run by the Memory and Aging Program at Butler Hospital in collaboration with the Alzheimer’s Association Rhode Island Chapter, the Alzheimer’s Association Massachusetts/New Hampshire Chapter, Director of The Weight Control and Diabetes Research Center at The Miriam Hospital Rena Wing Ph.D., and Kathryn E. Demos McDermott, Ph.D., Associate Professor of Psychiatry & Human Behavior at Brown University, who served as intervention director for the New England study site. In addition to the study site at Butler Hospital in Providence, the study is also being conducted at research sites in Chicago, Houston, Sacramento, and Winston-Salem, NC.
“Recruitment with a large number of participants for a lifestyle intervention study such as this is a huge accomplishment. We’re so proud of our team's hard work and dedication here at MAP and at our Providence-site partner organizations in reaching this milestone,” said MAP Director Edward Huey, MD.
MAP Founder and Principal Investigator for the Rhode Island site of the US POINTER Study Stephen Salloway, MD MS, noted that US POINTER is the largest trial MAP has conducted and that the site’s success in recruiting hundreds of participants for this critical study was thanks in large part to the enthusiastic support of community leaders and partners from across the region.
“We are so grateful to have met and exceeded our recruitment goals, and I think that speaks to the strength of the commitment from the study team and the people of Rhode Island and southeast New England to this cause,” says Dr. Salloway. “From the state leaders who helped us bring this study to Rhode Island, to community partners like Cardi’s Furniture Superstores, and local senior centers and senior agencies that helped us get the word out about this important initiative. And, of course, all the amazing individuals who have signed up to participate in the study, who have made this milestone possible, and whose participation will help to shed new light on critical information needed in the fight against Alzheimer’s.”
Dr. Wing echoes those sentiments saying, “We are thrilled with New England's interest in the U.S. POINTER Study and our clinic's great efforts toward reaching our recruitment goal. We are very excited to work with every one of the participants in the intervention over the next two years.”
Recruitment for U.S. POINTER also led to several new and significant partnerships between MAP and various community groups focused on raising awareness of the cultures and needs of diverse communities, including the Rhode Island Ministers’ Alliance.
Diversity is a Priority
A high-priority issue for the Alzheimer’s Association, the U.S. POINTER Study, and the Memory and Aging Program at Butler Hospital is to engage and include people from a wide range of racial, ethnic, socioeconomic, and geographic backgrounds who may be at increased risk of developing memory decline and dementia. Without appropriate participation from communities traditionally underrepresented in research, it is impossible to understand how racial and ethnic differences may affect the efficacy and safety of potential new treatments.
U.S. POINTER community-based teams recruited nearly 30% of participants from traditionally underrepresented communities in research, including racially and ethnically minoritized individuals and those from rural areas. As of March 2023, the overall U.S. POINTER Study participant population is:
- 16% Black
- 4.9% Hispanic
- 2.6% Asian
- 5.7% Other or Multiple
- 70.1% White
“The relationships we’ve built and the critical conversations we’ve had with diverse community leaders throughout Rhode Island as part of this study have been a game-changer for our program as a whole,” says MAP Associate Director Meghan Riddle, MD. “Our goal of achieving equitable representation in clinical research at our program extends to all our studies, not just U.S. POINTER. But this study provided the impetus to open the channels of communication and partnership required. Our ability to achieve health equity in research at our program is now greatly strengthened.”
Perhaps the most significant evidence is the Community Advisory Board established by the Memory and Aging Program. The Board includes individuals from diverse segments of the community who meet regularly with the MAP Outreach Team to advise on how to engage best with diverse populations in Alzheimer’s awareness, education, and research.
“The U.S. POINTER Study shows that the foundation of inclusion and representation in clinical research is collaboration with and in local communities,” says Carl V. Hill, Ph.D., MPH, Alzheimer’s Association Chief Diversity, Equity, and Inclusion Officer. “Garnering trust through grassroots engagement, utilizing faith-based community engagement models, and meeting people where they are have helped the study overcome long-standing challenges of underrepresentation in clinical research.”
Collaboration is Key
Butler Hospital President and COO Mary Marran, MS OT, MBA, said the US POINTER Study is an incredible example of what can be achieved when researchers, healthcare providers, community leaders, and community members come together.
“Alzheimer’s and other dementias affect a staggering number of people around the world – five million people in the U.S. alone – and those numbers are expected to grow exponentially in the years ahead,” Marran says. “The work being done across the country by the U.S. POINTER Study and around the globe by the World-Wide FINGERS Initiative has the potential to change that. Not only that but the partnerships and frameworks for sharing data that are being created are sure to accelerate research in the months and years to come. We at Butler Hospital are thrilled to be part of that effort and are excited to continue playing a role in what comes next.”
“This historic milestone is due to the incredible commitment of the participants, the partnerships across our study team and within communities, and the scientific rigor of the study design,” says Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “We are in an unprecedented new era of Alzheimer’s treatment. Behavioral and lifestyle interventions may be significant in future Alzheimer’s treatment and risk reduction. The results from U.S. POINTER will help define that role.”
