Percepta for Cognitive Optimization

ConditionsMild Cognitive Impairment (MCI)Memory

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-85

SponsorCerebrum DAO Association

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

154 Participants

are divided into 2 treatment groups

Group A: Percepta Intervention ArmExperimental treatment 1 intervention

Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Change in Total Sleep Time (Oura Ring) - Minutes

Time frame

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

Change in Sleep Efficiency (Oura Ring) - Percent

Time frame

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

Change in Sleep Latency (Oura Ring) - Minutes

Time frame

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

Change in Awake Time (Oura Ring) - Minutes

Time frame

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

Other outcomes

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

Time frame

Baseline (Month 0) and Month 6.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cerebrum DAO Association

Lead sponsor

Reputable Health

Collaborator

Source ClinicalTrials.gov

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