Percepta for Cognitive Optimization

NCT07612449 | Not Yet Recruiting

• 1 other identifier: CDA-2025-IPT-CT-001
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Memory

Keywords

Supplement; MCI

Outcome Measures

Primary Outcomes (1)

• Change in Digital MoCA Scores

  Unit: Points on MoCA scale (0-30) The Digital MoCA (eMoCA) is a validated, tablet-based version of the standard MoCA screening tool used to assess global cognitive function and detect mild cognitive impairment (MCI). The assessment evaluates multiple cognitive domains, including memory, executive function, visuospatial skills, attention, language, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance. The primary analysis evaluates the change in MoCA scores between the Percepta intervention group and the placebo group from baseline to the 6-month-endpoint. Additional analyses will assess the percent change from baseline and the proportion of participants achieving a Minimal Clinically Important Difference (MCID), defined as a ≥2-point improvement.

  Baseline (Month 0), Month 3, and Month 6

Secondary Outcomes (12)

• Change in Total Sleep Time (Oura Ring) - Minutes

  Baseline (Month 0), Month 3, and Month 6.

• Change in Sleep Efficiency (Oura Ring) - Percent

  Baseline (Month 0), Month 3, and Month 6.

• Change in Sleep Latency (Oura Ring) - Minutes

  Baseline (Month 0), Month 3, and Month 6.

• Change in Awake Time (Oura Ring) - Minutes

  Baseline (Month 0), Month 3, and Month 6.

• Change in REM Sleep Duration (Oura Ring) - Minutes

  Baseline (Month 0), Month 3, and Month 6.

Other Outcomes (1)

• Change in Plasma pTau-217 Concentration (Optional Sub-study) - Picograms per milliliter (pg/mL)

  Baseline (Month 0) and Month 6.

Study Arms (2)

Percepta Intervention Arm

EXPERIMENTAL

Participants in this arm will self-administer Percepta, a proprietary plant-based dietary supplement, orally once daily for a duration of 6 months. The daily dosage consists of 2 capsules totaling 750 mg. The supplement comprises PTI-00703® Cat's Claw (Uncaria tomentosa) bark extract and MemorTea™ oolong tea extract. Participants are instructed to take the capsules in the morning, preferably with a light meal, to minimize potential sleep disruption caused by the natural caffeine content found in the oolong tea extract. Percepta is designed to target underlying mechanisms of cognitive decline, including neuroinflammation, oxidative stress, and the accumulation of amyloid-beta plaques and tau tangles. Protocol adherence is monitored daily through the Reputable Health mobile application.

Dietary Supplement: Percepta

Placebo Arm

PLACEBO COMPARATOR

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 identical in size, color, 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.

Dietary Supplement: Placebo

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.

Also known as: PTI-00703 Cat's Claw

Percepta Intervention Arm

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.

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerebrum DAO Association: lead
• Reputable Health: collaborator

Study Sites (1)

Reputable Health

Wilmington, Delaware, 19808, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Mackenzie De Jesus, DHSc, MS

CONTACT

754-301-9531; mackenzie@reputable.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)