Percepta for Cognitive Optimization: A 6-Month Randomized Controlled Trial With Neurocognitive, Wearable, and Participant-Reported Outcomes in Adults With Mild Cognitive Impairment

Summary

This Phase 1, randomized, double-blind, placebo-controlled trial evaluates the cognitive and neurophysiological effects of a dietary supplement containing cat's claw (Uncaria tomentosa) bark extract and oolong tea extract, in adults aged 40-85 with self-reported mild cognitive impairment (MCI). The study employs a decentralized design leveraging remote monitoring technologies. Participants will self-administer the study supplement or a matched placebo daily for 6 months. The primary outcome is cognitive performance assessed by digital Montreal Cognitive Assessment (MoCA) at baseline, Month 3, and Month 6. Secondary outcomes include objective sleep and autonomic metrics from Oura Ring wearables (heart rate variability, sleep architecture) and self-reported brain health using the Brain Health Index. An exploratory sub-study will measure plasma biomarkers of neurodegeneration (pTau-217) at baseline and Month 6 in a subset of participants to explore potential mechanisms of action. The study aims to provide preliminary evidence for Percepta's efficacy in improving cognitive function and supporting brain health in individuals with MCI, while evaluating safety and biological plausibility through mechanistic biomarkers.

Description