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Mild Cognitive Impairment (MCI)PFCONCT07612449

Percepta for Cognitive Optimization

A study testing Percepta in people with Mild Cognitive Impairment (MCI) and Memory, run by Cerebrum DAO Association at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Mild Cognitive Impairment (MCI), Memory
What is being tested?
Percepta
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
1 siteUnited States
Study dates
14 Sep 2026to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mackenzie De Jesus, DHSc, MS contact

754-301-9531

mackenzie@reputable.health

United States1 site, 1 recruiting
  • Reputable Health

    Wilmington, Delaware, 19808

    Recruiting

Other trials in United States

About this study

Official title: Percepta for Cognitive Optimization: A 6-Month Randomized Controlled Trial With Neurocognitive, Wearable, and Participant-Reported Outcomes in Adults With Mild Cognitive Impairment

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.

Read more

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.

Read the detailed 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 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.

Being tested
Percepta, Placebo
Keywords
Supplement, MCI
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerceptaDietary supplement

    Also called PTI-00703 Cat's Claw

    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.

  • PlaceboDietary 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.

Study groups in NCT07612449
Study groupRoleWhat they receive
Percepta Intervention ArmExperimentalParticipants 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.
Receives: Dietary Supplement: Percepta
Placebo ArmPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)
  1. Change in Total Sleep Time (Oura Ring) - Minutes

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

  2. Change in Sleep Efficiency (Oura Ring) - Percent

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

  3. Change in Sleep Latency (Oura Ring) - Minutes

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

  4. Change in Awake Time (Oura Ring) - Minutes

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

  5. Change in REM Sleep Duration (Oura Ring) - Minutes

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

  6. Change in Deep Sleep Duration (Oura Ring) - Minutes

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

  7. Change in Light Sleep Duration (Oura Ring) - Minutes

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

  8. Change in Resting Heart Rate - Average (Oura Ring) - Beats per minute (bpm)

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

  9. Change in Resting Heart Rate - Lowest (Oura Ring) - Beats per minute (bpm)

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

  10. Change in Average Heart Rate During Sleep (Oura Ring) - Beats per minute (bpm)

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

  11. Change in Heart Rate Variability (Oura Ring) - Milliseconds (RMSSD)

    Root Mean Square of Successive Differences (RMSSD) calculates the variance in time (in milliseconds) between consecutive heartbeats in order to measure the change in Heart Rate Variability (HRV).

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

  12. Change in Brain Health Index Total Score - Points (0-100 scale)

    Assessment of participant-reported brain health using the Brain Health Index (BHI), a validated tool that quantifies subjective mental clarity and cognitive fatigue. The BHI integrates structured assessments across three core domains: Clarity (cognitive flexibility and memory), Connectedness (social support and emotional regulation), and Emotional Balance (stress resilience and mood regulation). The BHI generates a composite score ranging from 0 to 100, with higher scores indicating better self-perceived cognitive function and brain health.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start14 Sep 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612449
Sponsor's protocol ID
CDA-2025-IPT-CT-001
Acronym
PFCO
Status last verified
Sep 2026
First submitted
8 Jan 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. Only de-identified, aggregated results may be disseminated in publications or reports. All data collected through the Reputable Health platform are encrypted and stored in a secure, access-controlled environment, and no individual-level data will be made publicly available.

Questions about this trial

What is this clinical trial studying?

A study testing Percepta in people with Mild Cognitive Impairment (MCI) and Memory, run by Cerebrum DAO Association at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mackenzie De Jesus, DHSc, MS (754-301-9531, mackenzie@reputable.health), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Digital MoCA Scores (time frame: Baseline (Month 0), Month 3, and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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