Percepta for Cognitive Optimization

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.

Interventions

• Percepta · DIETARY_SUPPLEMENT

  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.

• Placebo · DIETARY_SUPPLEMENT

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 and Compliance: Must provide signed informed consent and demonstrate a willingness to comply with all study procedures, including assessments and lifestyle considerations.

Exclusion Criteria:

* Neurological and Psychiatric Disorders: A self-reported diagnosis of dementia, Alzheimer's disease, Parkinson's disease, depressive disorders, bipolar disorder, schizophrenia, epilepsy, multiple sclerosis, or substance use disorder. This also includes a history of stroke, traumatic brain injury (TBI), intracranial hemorrhage, or seizure disorders.
* Medication Use: Current use of cognitive-affecting medications or supplements, such as donepezil, memantine, methylphenidate, benzodiazepines, antipsychotics, or nootropics.
* Allergies: Known allergy or sensitivity to cat's claw or oolong tea,. Reproductive Status: Currently pregnant, breastfeeding, or planning to become pregnant within the next 12 months.
* Genetic Risk: Known carrier of the APOE-4 allele.
* Recent Study Participation: Enrollment in another clinical trial or intervention study within the past 30 days.

Sites (1)

• Reputable Health, Wilmington, Delaware