CHICAGO, March 8, 2023
— Leaders of the U.S. POINTER Study announced a historic milestone: recruiting for the clinical trial has been successfully completed.
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 that target many risk factors can protect cognitive function in older adults who are at increased risk for cognitive decline. U.S. POINTER is the first such study to be conducted in a large, diverse group of Americans across the United States.
More than 2,000 volunteers are enrolled across five study sites, based in Chicago; Houston; Providence, R.I.; Sacramento, Calif.; and Winston-Salem, N.C.. U.S. POINTER community-based teams recruited nearly 30% of participants from communities that are traditionally underrepresented in research, including racially and ethnically minoritized individuals and those from rural areas.
As of March 6, 2023, the U.S. POINTER Study population is 16% Black, 4.9% Hispanic, 2.6% Asian, 5.7% Other or Multiple, and 70.1% White. A high priority issue for the Alzheimer’s Association and the U.S. POINTER Study 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.
“First, we must acknowledge and celebrate those who have volunteered for the study. They are the heart and soul of this effort, and we will deliver on the trust they and their families are putting in us,” said U.S. POINTER Study Principal Investigator Laura Baker, Ph.D., professor of internal medicine and associate director of the Wake Forest Alzheimer’s Disease Center at the Wake Forest University School of Medicine. “This accomplishment is a testament to the tremendous commitment and investment by this research team, not only to the study, but also to the care of our U.S. POINTER participants.”
“The U.S. POINTER Study shows that the foundation of inclusion and representation in clinical research is collaboration with and in local communities,” said 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 helped the study overcome long-standing challenges of underrepresentation in clinical research.”
“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,” said 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 play a significant role in future Alzheimer’s treatment and risk reduction. The results from U.S. POINTER will help define that role.”
Without appropriate participation from communities that are traditionally underrepresented in research, it is impossible to get a complete understanding of how racial and ethnic differences may affect the efficacy and safety of potential new treatments. The Alzheimer’s Association is committed to ensuring that studies reflect the entire population so everyone benefits from advances in Alzheimer’s and all dementia research.
More About the U.S. POINTER Study
Two lifestyle interventions are being compared in the study, which vary in intensity and format. Eligible volunteers are randomly assigned to these interventions to evaluate whether cognitive benefits from a structured program differ from a self-guided program.
Data from the US POINTER study is expected in 2025. Four “add-on” studies are looking deeper into the science of the main study:
- The U.S. POINTER Neuroimaging Ancillary Study (NIH grant R01AG062689).
- The U.S. POINTER-zzz Sleep Study (NIH grant 5R01AG064440-03).
- The POINTER-Microbiome Study (NIH grant 5U19AG063744-03).
- The U.S. POINTER NeuroVascular (NV) Study (NIH grant R01AG066910).
Lifestyle interventions combining multiple behavior components show promise as a therapeutic strategy to protect brain health. The two-year FINGER
study reported that a combination of physical activity, nutritional guidance, cognitive training, social activities and management of heart-health risk factors protected cognition in healthy older adults with an increased risk of cognitive decline. There is an urgent need to expand this work to test the generalizability, adaptability and sustainability of the FINGER study's findings in geographically and culturally diverse populations worldwide.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.