Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline

Rachel A Whitmer¹, Laura D Baker^{2

3}, Maria C Carrillo⁴, Heather M Snyder⁴, MaryJo L Cleveland², Darren R Gitelman⁵, Miia Kivipelto^{6

7

8

9}, Xiaoyan I Leng³, Laura Lovato³, Kathryn V Papp¹⁰, Valory N Pavlik¹¹, Stephen P Salloway¹², Christy C Tangney¹³, Sarah Tomaszewski Farias¹⁴, Jeff D Williamson², Sharon Wilmoth², Nancy Woolard², Melissa Yu¹¹, Mark Andrew Espeland^{2

3}; U.S. POINTER Study Group

Affiliations

¹ Department of Public Health Sciences, University of California Davis, Davis, California, USA.
² Department of Internal Medicine, Wake Forest University School of Medicine, The Sticht Center for Healthy Aging and Alzheimer's Prevention, -Salem, Winston, North Carolina, USA.
³ Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
⁴ Alzheimer's Association, Medical and Scientific Relations, Alzheimer's Association, Chicago, Illinois, USA.
⁵ Department of Neuropsychiatry, Advocate Health, Chicago, Illinois, USA.
⁶ Division of Clinical Geriatrics, Center for Alzheimer Research, Karolinska Institutet, Stockholm, Sweden.
⁷ University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, Finland.
⁸ Imperial College London, School of Public Health, Ageing Epidemiology Research Unit, London, UK.
⁹ FINGERS Brain Health Institute, Solna, Sweden.
¹⁰ Department of Neurology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹¹ Department of Neurology, Baylor College of Medicine, Houston, Texas, USA.
¹² Butler Hospital, Memory and Aging Program, and Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
¹³ Departments of Clinical Nutrition, and Family and Preventive Medicine, Rush University Medical Center, Chicago, Illinois, USA.
¹⁴ Department of Neurology, University of California Davis, Sacramento, California, USA.

PMID: 40556311
PMCID: PMC12187955
DOI: 10.1002/alz.70351

Randomized Controlled Trial

Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline

Rachel A Whitmer et al. Alzheimers Dement. 2025 Jun.

. 2025 Jun;21(6):e70351.

doi: 10.1002/alz.70351.

Authors

Affiliations

¹ Department of Public Health Sciences, University of California Davis, Davis, California, USA.
² Department of Internal Medicine, Wake Forest University School of Medicine, The Sticht Center for Healthy Aging and Alzheimer's Prevention, -Salem, Winston, North Carolina, USA.
³ Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
⁴ Alzheimer's Association, Medical and Scientific Relations, Alzheimer's Association, Chicago, Illinois, USA.
⁵ Department of Neuropsychiatry, Advocate Health, Chicago, Illinois, USA.
⁶ Division of Clinical Geriatrics, Center for Alzheimer Research, Karolinska Institutet, Stockholm, Sweden.
⁷ University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, Finland.
⁸ Imperial College London, School of Public Health, Ageing Epidemiology Research Unit, London, UK.
⁹ FINGERS Brain Health Institute, Solna, Sweden.
¹⁰ Department of Neurology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹¹ Department of Neurology, Baylor College of Medicine, Houston, Texas, USA.
¹² Butler Hospital, Memory and Aging Program, and Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
¹³ Departments of Clinical Nutrition, and Family and Preventive Medicine, Rush University Medical Center, Chicago, Illinois, USA.
¹⁴ Department of Neurology, University of California Davis, Sacramento, California, USA.

PMID: 40556311
PMCID: PMC12187955
DOI: 10.1002/alz.70351

Abstract

Introduction: The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a 2-year randomized controlled trial of two lifestyle interventions in 2111 older adults at increased risk for cognitive decline.

Methods: Sociodemographic and clinical characteristics and rates of ancillary study participation were described with means and frequencies.

Results: U.S. POINTER successfully enrolled a cohort, ages 60-79 years, which was ethno-racially inclusive (>30% individuals from groups often under-represented in clinical trials with cognitive outcomes) and 18% residing in neighborhoods with moderate or high levels of socioeconomic deprivation. Enrollees were cognitively intact but at increased risk for cognitive decline. Participation in ancillary studies (overall 73%) was uniformly high across sociodemographic groups.

Discussion: The trial cohort meets study goals and provides a basis for assessing multidomain lifestyle intervention effects on cognitive function and other health outcomes that will generalize to large portions of the at-risk US populations.

Gov identifier: NCT00017953.

Highlights: The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) enrolled individuals at enhanced risk for cognitive decline. Efforts to engage socio-demographically representative individuals were successful. Four ancillary studies with high rate of recruitment extend scientific impact.

Keywords: Alzheimer's disease; ancillary studies; cognitive function; multidomain lifestyle interventions; randomized controlled clinical trial; recruitment; risk factors.

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Conflict of interest statement

U.S. POINTER was conceived and developed in partnership with the Alzheimer's Association. Drs. Carrillo and Snyder, full‐time employees of the Alzheimer's Association, have contributed to the study design, trial oversight, manuscript preparation, and the decision to submit the article for publication. The authors have no conflicts to report. Author disclosures are available in the supporting information.

References

1. Livingston G, Huntley J, Sommerland A, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020;396(10248):413‐446. - PMC - PubMed
1. SPRINT MIND Investigators for the SPRINT Research Group . Effect of intensive vs standard blood pressure control on probable dementia: a randomized clinical trial. JAMA. 2019;321(6):553‐561. - PMC - PubMed
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Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline

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Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline

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Abstract

Conflict of interest statement

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