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

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. CLINICALTRIALS.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.