LatAm‐FINGERS and U.S. POINTER: Design and Cohort Characteristics of Parallel Harmonized Trials of Multidomain Lifestyle Interventions Targeting Cognition

Abstract

AbstractBackgroundMultidomain lifestyle interventions hold great promise world‐wide as interventions to slow cognitive aging, and delay and prevent Alzheimer’s Disease and Related Disorders (ADRD). To have the greatest reach, they must be tailored for and assessed within local cultures in clinical trials. For trials to have the greatest impact, it’s important that they are designed with common features that promote comparisons and potential harmonization.MethodWorld‐Wide FINGERS was launched in 2017 as a global network of multidomain lifestyle intervention trials to adapt, test, and optimize multidomain lifestyle intervention trials in regions worldwide. Two participating trials, the Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm‐FINGERS) and the U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk (U.S. POINTER) have collaborated to promote harmonization to support joint initiatives. This presentation is organized to describe, in parallel, their study protocols, and cohort characteristics, and demonstrate how cross‐trial collaboration may expand the impact of individual trials.ResultThe trials have overlapping aims, eligibility criteria, interventions, and assessment protocols. LatAm‐FINGERS and U.S. POINTER will enroll 1,200 and 2,000 participants, respectively. Table 1 describes sample characteristics. The samples of the two studies share similar sociodemographic and clinical characteristics with a few exceptions. In U.S. POINTER, there is a larger proportion of participants with a family history of memory impairment and physical inactivity, and a higher frequency of White participants. Additionally, mild memory impairment (Clinical Dementia Rating = 0.5) is more common in LatAm‐FINGERS participants.ConclusionHarmonization of LatAm‐FINGERS and U.S. POINTER protocols provides unique opportunities for collaborative science for identifying effective strategies to promote cognitive resilience and reduce risks for Alzheimer’s disease, and significantly expand the potential for scientific investigation in diverse populations.