U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Baseline Characteristics of a Trial Cohort Enriched for Risk of Cognitive Decline

Abstract

AbstractBackgroundU.S. POINTER is a two‐year clinical trial to evaluate whether lifestyle interventions targeting multiple risk factors protect cognitive function in older adults at increased risk for cognitive decline. We describe the baseline characteristics of the U.S. POINTER clinical trial cohort overall, and before and after changes in risk factor enrichment inclusion criteria.MethodU.S. POINTER is a Phase 3, multicenter, randomized 2‐year clinical trial of two lifestyle interventions varying in intensity and format, in older adults at increased risk for cognitive decline and dementia. The study closed enrollment with 2111 individuals at 5 sites (North Carolina, Northern California, Chicagoland, Houston, Rhode Island). Eligible participants were sedentary and consumed a suboptimum diet and met other risk enrichment criteria that included first degree family history of memory impairment, and suboptimum cardiovascular health status (meeting specific cut‐points of systolic blood pressure, LDL cholesterol or hemoglobin A1c). 20 months into enrollment, risk enrichment criteria were revised to account for two other factors: older age (70‐79 years), and African American/Black or Native American race or Hispanic/Latine ethnicity.ResultMean age at baseline is 68.2 years, 31% represent communities of color, 69% are women, and 30% are not college graduates. 58% reported maternal memory loss, mean systolic blood pressure = 131 mmHg, mean total cholesterol = 193 mg/dl, mean HbA1C = 5.9%, and mean body mass index (BMI) = 29.9 kg/m2. Mean adjusted modified Telephone Interview for Cognitive Status (TICSm) score is = 37.6 (max = 50 pts), Geriatric Depression Score (GDS) is = 1.8, and Short Physical Performance Battery Chair Stand Score (SPBC) is = 3.3. Some baseline characteristics (BMI, total cholesterol, SBBP chair stand) vary by clinical site. The change to risk score enrichment criteria (Table 1) increased representation of participants from communities of color and number of males in the study cohort.ConclusionU.S. POINTER successfully enrolled 2111 participants across 5 sites who are at high risk for cognitive decline and dementia, with appropriate representation by groups typically underrepresented in clinical trials, individuals aged 75 or older, and men, with the expansion of risk score enrichment criteria.