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
Authors
Rachel A. Whitmer, Department of Public Health Sciences, University of California Davis, Davis, California, USA.
Laura D. Baker, 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.
Maria C. Carrillo, Alzheimer's Association, Medical and Scientific Relations, Alzheimer's Association, Chicago, Illinois, USA.
Heather M. Snyder, Alzheimer's Association, Medical and Scientific Relations, Alzheimer's Association, Chicago, Illinois, USA.
MaryJo L. Cleveland, 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.
Darren R. Gitelman, Advocate Health - MidwestFollow
Miia Kivipelto, Division of Clinical Geriatrics, Center for Alzheimer Research, Karolinska Institutet, Stockholm, Sweden.
Xiaoyan I. Leng, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Laura Lovato, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Kathryn V. Papp, Department of Neurology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Valory N. Pavlik, Department of Neurology, Baylor College of Medicine, Houston, Texas, USA.
Stephen P. Salloway, Butler Hospital, Memory and Aging Program, and Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Christy C. Tangney, Departments of Clinical Nutrition, and Family and Preventive Medicine, Rush University Medical Center, Chicago, Illinois, USA.
Sarah Tomaszewski Farias, Department of Neurology, University of California Davis, Sacramento, California, USA.
Jeff D. Williamson, 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.
Sharon Wilmoth, 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.
Nancy Woolard, 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.
Melissa Yu, Department of Neurology, Baylor College of Medicine, Houston, Texas, USA.
Mark Andrew Espeland, 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.
Recommended Citation
Whitmer RA, Baker LD, Carrillo MC, et al. 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. Alzheimers Dement. 2025;21(6):e70351. 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.
