Randomized Controlled Trial

. 2024 Feb;20(2):769-782.

doi: 10.1002/alz.13365. Epub 2023 Sep 30.

Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER)

Laura D Baker^{1

2

3}, Heather M Snyder⁴, Mark A Espeland^{1

2}, Rachel A Whitmer⁵, Miia Kivipelto^{6

7

8

9}, Nancy Woolard¹, Jeffrey Katula¹⁰, Kathryn V Papp^{11

12

13}, Jennifer Ventrelle¹⁴, Sarah Graef¹⁴, Marcus A Hill¹, Scott Rushing², Julia Spell², Laura Lovato², Deborah Felton², Benjamin J Williams³, Mina Ghadimi Nouran¹, Rema Raman¹⁵, Tiia Ngandu^{6

16}, Alina Solomon^{6

8

9

17}, Sharon Wilmoth¹, Maryjo L Cleveland¹, Jeff D Williamson¹, Katherine L Lambert¹⁸, Sarah Tomaszewski Farias¹⁹, Claire E Day²⁰, Christy C Tangney¹⁵, Darren R Gitelman²¹, Olivia Matongo²², Terrianne Reynolds²², Valory N Pavlik²³, Melissa M Yu²³, Ashley S Alexander²⁴, Richard Elbein²⁵, Ann Marie McDonald²⁵, Stephen Salloway²⁶, Rena R Wing²⁷, Susan Antkowiak²⁸, Martha Clare Morris^#¹⁴, Maria C Carrillo⁴; U.S. POINTER Study Group

Affiliations

¹ Wake Forest University School of Medicine, Department of Internal Medicine, Winston Salem, North Carolina, USA.
² Wake Forest University School of Medicine, Division of Public Health Sciences, Winston Salem, North Carolina, USA.
³ Wake Forest University School of Medicine, Department of Neurology, Winston Salem, North Carolina, USA.
⁴ Alzheimer's Association, Chicago, Illinois, USA.
⁵ University of California Davis, Department of Public Health Sciences, Sacramento, California, USA.
⁶ Karolinska Institute, Division of Clinical Geriatrics, Center for Alzheimer Research, 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, Stockholm, Sweden.
¹⁰ Wake Forest University, Department of Health and Exercise Science, Winston Salem, North Carolina, USA.
¹¹ Brigham and Women's Hospital, Department of Neurology, Boston, Massachusetts, USA.
¹² Massachusetts General Hospital, Department of Neurology, Boston, Massachusetts, USA.
¹³ Harvard Medical School, Department of Neurology, Boston, Massachusetts, USA.
¹⁴ Rush University Medical Center, Departments of Clinical Nutrition, and Family and Preventive Medicine, Chicago, Illinois, USA.
¹⁵ University of Southern California, Alzheimer's Therapeutic Research Institute, San Diego, California, USA.
¹⁶ Finnish Institute for Health and Welfare, Department of Public Health and Welfare, Helsinki, Finland.
¹⁷ University of Eastern Finland, Institute of Clinical Medicine/Neurology, Kuopio, Finland.
¹⁸ Alzheimer's Association, Western Carolina Chapter, Charlotte, North Carolina, USA.
¹⁹ University of California Davis, Department of Neurology, Sacramento, California, USA.
²⁰ Alzheimer's Association, Northern California Northern Nevada Chapter, San Jose, California, USA.
²¹ Advocate Health Care, Department of Behavioral Neurology, Downers Grove, Illinois, USA.
²² Alzheimer's Association, Illinois Chapter, Chicago, Illinois, USA.
²³ Baylor College of Medicine, Department of Neurology, Houston, Texas, USA.
²⁴ Kelsey Research Foundation, Houston, Texas, USA.
²⁵ Alzheimer's Association, Houston & Southeast Texas Chapter, Houston, Texas, USA.
²⁶ Butler Hospital, Memory and Aging Program, and Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
²⁷ Brown University, Department of Psychiatry and Human Behavior, School of Medicine, Providence, Rhode Island, USA.
²⁸ Alzheimer's Association, Rhode Island Chapter, Providence, Rhode Island, USA.

^# Contributed equally.

PMID: 37776210
PMCID: PMC10916955
DOI: 10.1002/alz.13365

Randomized Controlled Trial

Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER)

Laura D Baker et al. Alzheimers Dement. 2024 Feb.

. 2024 Feb;20(2):769-782.

doi: 10.1002/alz.13365. Epub 2023 Sep 30.

Authors

Affiliations

¹ Wake Forest University School of Medicine, Department of Internal Medicine, Winston Salem, North Carolina, USA.
² Wake Forest University School of Medicine, Division of Public Health Sciences, Winston Salem, North Carolina, USA.
³ Wake Forest University School of Medicine, Department of Neurology, Winston Salem, North Carolina, USA.
⁴ Alzheimer's Association, Chicago, Illinois, USA.
⁵ University of California Davis, Department of Public Health Sciences, Sacramento, California, USA.
⁶ Karolinska Institute, Division of Clinical Geriatrics, Center for Alzheimer Research, 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, Stockholm, Sweden.
¹⁰ Wake Forest University, Department of Health and Exercise Science, Winston Salem, North Carolina, USA.
¹¹ Brigham and Women's Hospital, Department of Neurology, Boston, Massachusetts, USA.
¹² Massachusetts General Hospital, Department of Neurology, Boston, Massachusetts, USA.
¹³ Harvard Medical School, Department of Neurology, Boston, Massachusetts, USA.
¹⁴ Rush University Medical Center, Departments of Clinical Nutrition, and Family and Preventive Medicine, Chicago, Illinois, USA.
¹⁵ University of Southern California, Alzheimer's Therapeutic Research Institute, San Diego, California, USA.
¹⁶ Finnish Institute for Health and Welfare, Department of Public Health and Welfare, Helsinki, Finland.
¹⁷ University of Eastern Finland, Institute of Clinical Medicine/Neurology, Kuopio, Finland.
¹⁸ Alzheimer's Association, Western Carolina Chapter, Charlotte, North Carolina, USA.
¹⁹ University of California Davis, Department of Neurology, Sacramento, California, USA.
²⁰ Alzheimer's Association, Northern California Northern Nevada Chapter, San Jose, California, USA.
²¹ Advocate Health Care, Department of Behavioral Neurology, Downers Grove, Illinois, USA.
²² Alzheimer's Association, Illinois Chapter, Chicago, Illinois, USA.
²³ Baylor College of Medicine, Department of Neurology, Houston, Texas, USA.
²⁴ Kelsey Research Foundation, Houston, Texas, USA.
²⁵ Alzheimer's Association, Houston & Southeast Texas Chapter, Houston, Texas, USA.
²⁶ Butler Hospital, Memory and Aging Program, and Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
²⁷ Brown University, Department of Psychiatry and Human Behavior, School of Medicine, Providence, Rhode Island, USA.
²⁸ Alzheimer's Association, Rhode Island Chapter, Providence, Rhode Island, USA.

^# Contributed equally.

PMID: 37776210
PMCID: PMC10916955
DOI: 10.1002/alz.13365

Abstract

Introduction: The U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER) is conducted to confirm and expand the results of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) in Americans.

Methods: U.S. POINTER was planned as a 2-year randomized controlled trial of two lifestyle interventions in 2000 older adults at risk for dementia due to well-established factors. The primary outcome is a global cognition composite that permits harmonization with FINGER.

Results: U.S. POINTER is centrally coordinated and conducted at five clinical sites (ClinicalTrials.gov: NCT03688126). Outcomes assessments are completed at baseline and every 6 months. Both interventions focus on exercise, diet, cognitive/social stimulation, and cardiovascular health, but differ in intensity and accountability. The study partners with a worldwide network of similar trials for harmonization of methods and data sharing.

Discussion: U.S. POINTER is testing a potentially sustainable intervention to support brain health and Alzheimer's prevention for Americans. Impact is strengthened by the targeted participant diversity and expanded scientific scope through ancillary studies.

Keywords: Alzheimer's disease; aging; clinical trial; cognition; cognitive training; diet; exercise; lifestyle intervention; non-pharmacological; prevention; risk modification.

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Conflict of interest statement

U.S. POINTER was conceived and developed in partnership with the Alzheimer's Association. Drs. Snyder and Carrillo, 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.

Figures

**FIGURE 1**
Overview of intervention arms.

**FIGURE 2**
Stages of recruitment and enrollment.

See this image and copyright information in PMC

References

1. Livingston G, Huntley J, Sommerlad A, et al. Dementia prevention, intervention, and care: 2020 report of the lancet commission. Lancet. 2020;396(10248):413‐446. - PMC - PubMed
1. National Academies of Sciences E, Medicine, Health, Medicine D, Board on Health Sciences P, Committee on Preventing D, Cognitive I . In Downey A, Stroud C, Landis S, Leshner AI, eds. Preventing Cognitive Decline and Dementia: A Way Forward. National Academies Press (US); 2017. - PubMed
1. Committee on the Public Health Dimensions of Cognitive A, Board on Health Sciences P, Institute of M . The National academies collection: reports funded by National Institutes of Health. In Blazer DG, Yaffe K, Liverman CT, eds. The National academies collection: reports funded by National institutes of health. Cognitive Aging: Progress in Understanding and Opportunities for Action. National Academies Press (US); 2015. - PubMed
1. Baumgart M, Snyder HM, Carrillo MC, Fazio S, Kim H, Johns H. Summary of the evidence on modifiable risk factors for cognitive decline and dementia: a population‐based perspective. Alzheimers Dement. 2015;11(6):718‐726. - PubMed
1. WHO Guidelines Approved by the Guidelines Review Committee . In: Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. World Health Organization; 2019. - PubMed

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Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER)

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Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER)

Authors

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Conflict of interest statement

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