Percepta for Cognitive Optimization (PFCO)

Study Rationale and Background Mild Cognitive Impairment (MCI) represents a critical transitional stage between normal cognitive aging and neurodegenerative conditions such as Alzheimer's disease. Current intervention strategies are limited, creating a need for accessible, non-pharmacological therapies that target multiple pathways of cognitive decline. Percepta is a plant-based dietary supplement composed of PTI-00703 Cat's Claw (*Uncaria tomentosa*) bark extract and MemorTea oolong tea extract,. Preclinical research suggests these ingredients may modulate neuroinflammation, reduce oxidative stress, and disrupt the accumulation of amyloid-beta plaques and tau tangles,,. This study aims to bridge the gap in MCI research by systematically evaluating the combined effects of these compounds 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 in a 1:1 ratio to receive either the active Percepta supplement or a matched placebo,. The study duration is 6 months, with a potential optional extension to 12 months based on interim analysis results at the 3-month midpoint.

Intervention Participants in the active arm will self-administer Percepta orally at a dose of 750 mg (2 capsules) once daily, preferably in the morning to avoid sleep disruption from natural caffeine content. The placebo group will receive identical capsules devoid of active ingredients. Compliance is tracked daily via the Reputable Health mobile application, with a requirement of ≥80% adherence for per-protocol analysis.

Study Procedures Screening and Baseline: Eligibility is determined via an online screening survey and digital MoCA. Upon enrollment, participants complete baseline BHI surveys, medical history questionnaires, and sync their wearable devices.

Remote Monitoring: The trial leverages a decentralized platform. Participants log daily supplement 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) are administered at Baseline (Month 0), Midpoint (Month 3), and Endpoint (Month 6).

Safety Monitoring: Safety is assessed through continuous monitoring of wearable biomarkers for significant deviations and participant self-reporting of AEs. Serious Adverse 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 meaningful difference in the primary endpoint (MoCA score change) using an independent-samples t-test with a two-sided alpha of 0.05, accounting for a 20% attrition rate,,. Efficacy analyses will be performed on the Intention-To-Treat (ITT) population (≥95% adherence) and the Per Protocol (PP) population (≥80% adherence). Secondary endpoints will be analyzed using mixed-effects models to account for repeated measures. Subgroup analyses will explore effects based on age, sex, baseline cognitive status, and other demographic factors.