Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER)
Laura D. Baker, Heather M. Snyder, Mark A. Espeland, Rachel A. Whitmer, Miia Kivipelto, Nancy Woolard, Jeffrey A. Katula, Kathryn V. Papp, Jennifer Ventrelle, Sarah Graef, Marcus Hill, Scott Rushing, J. R. Spell, Laura Lovato, Deborah Felton, Benjamin J. Williams, Mina Ghadimi Nouran, Rema Raman, Tiia Ngandu, Alina Solomon, Sharon Wilmoth, Maryjo Cleveland, Jeff D. Williamson, Katherine L. Lambert, Sarah Tomaszewski Farias, Claire E. Day, Christy Tangney, Darren R. Gitelman, Olivia Matongo, Terrianne Reynolds, Valory Pavlik, Melissa Yu, Ashley S. Alexander, Richard Elbein, Ann Marie McDonald, Stephen Salloway, Rena R. Wing, Susan Antkowiak, Martha Clare Morris, María C. Carrillo, for the U.S. POINTER Study Group
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.