Percepta for Cognitive Optimization

Study Rationale and Background Mild Cognitive Impairment (MCI) represents a criticaltransitional stage between normal cognitive aging and neurodegenerative conditions suchas Alzheimer's disease. Current intervention strategies are limited, creating a need foraccessible, non‐pharmacological therapies that target multiple pathways of cognitivedecline. Percepta is a plant‐based dietary supplement composed of PTI‐00703 Cat's Claw(*Uncaria tomentosa*) bark extract and MemorTea oolong tea extract,. Preclinical researchsuggests these ingredients may modulate neuroinflammation, reduce oxidative stress, anddisrupt the accumulation of amyloid‐beta plaques and tau tangles,,. This study aims tobridge the gap in MCI research by systematically evaluating the combined effects of thesecompounds in a human population.Study Design This is a Phase 1, randomized, double‐blind, placebo‐controlled,decentralized clinical trial. A total of 154 eligible participants will be randomized ina 1:1 ratio to receive either the active Percepta supplement or a matched placebo,. Thestudy duration is 6 months, with a potential optional extension to 12 months based oninterim analysis results at the 3‐month midpoint.Intervention Participants in the active arm will self‐administer Percepta orally at adose of 750 mg (2 capsules) once daily, preferably in the morning to avoid sleepdisruption from natural caffeine content. The placebo group will receive identicalcapsules devoid of active ingredients. Compliance is tracked daily via the ReputableHealth mobile application, with a requirement of ≥80% adherence for per‐protocolanalysis.Study Procedures Screening and Baseline: Eligibility is determined via an onlinescreening survey and digital MoCA. Upon enrollment, participants complete baseline BHIsurveys, medical history questionnaires, and sync their wearable devices.Remote Monitoring: The trial leverages a decentralized platform. Participants log dailysupplement intake and report any adverse events (AEs) through the app. Biometric data(sleep, HRV) is passively collected continuously.Assessments: Cognitive assessments (MoCA) and self‐reported outcomes (BHI) areadministered at Baseline (Month 0), Midpoint (Month 3), and Endpoint (Month 6).Safety Monitoring: Safety is assessed through continuous monitoring of wearablebiomarkers for significant deviations and participant self‐reporting of AEs. SeriousAdverse Events (SAEs) must be reported to the IRB and Sponsor within 48 hours.Statistical Analysis The sample size of 154 provides 80% power to detect a meaningfuldifference in the primary endpoint (MoCA score change) using an independent‐samplest‐test with a two‐sided alpha of 0.05, accounting for a 20% attrition rate,,. Efficacyanalyses will be performed on the Intention‐To‐Treat (ITT) population (≥95% adherence)and the Per Protocol (PP) population (≥80% adherence). Secondary endpoints will beanalyzed using mixed‐effects models to account for repeated measures. Subgroup analyseswill explore effects based on age, sex, baseline cognitive status, and other demographicfactors.