Percepta for Cognitive Optimization: A 6-Month Randomized Controlled Trial With Neurocognitive, Wearable, and Participant-Reported Outcomes in Adults With Mild Cognitive Impairment
Cerebrum DAO Association
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
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 oxidativ…
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Demographics: Must be English-speaking and currently residing in the United States. * Cognitive Status: Must have self-reported cognitive impairment, defined specifically by a Montreal Cognitive Assessment (MoCA) score of less than 25. * Technology Access: Must own an Oura Ring, maintain an active membership throughout the study, and have consistent access to a smartphone for app-based surveys and data syncing. * Medical Stability: Must be in good general health and medically stable, with no significant health changes in the three months prior to enrollment. * Consent an…
Interventions
- Dietary SupplementPercepta
Percepta is a plant-based natural dietary supplement consisting of PTI-00703 cat's claw sourced from the Amazon rainforest and and MemorTea, an oolong tea extract.
- Dietary SupplementPlacebo
Participants in this arm will self-administer a matched placebo supplement orally once daily for a duration of 6 months. The placebo consists of capsules containing an inert substance, devoid of the active Percepta ingredients (PTI-00703® Cat's Claw and MemorTea™ oolong tea extracts). To maintain the double-blind design, the placebo capsules are manufactured to be visually similar in size and packaging to the active intervention. The dosing regimen mirrors the active arm: participants are instructed to take 2 capsules in the morning, preferably with a light meal. Adherence is tracked daily via the Reputable Health mobile application. This arm serves as a comparator to isolate the specific effects of Percepta from potential placebo responses.
Location
- Reputable HealthWilmington, Delaware