Percepta for Cognitive Optimization: A 6-Month Randomized Controlled Trial With Neurocognitive, Wearable, and Participant-Reported Outcomes in Adults With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Percepta Intervention Arm
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.
干预措施: Percepta (Dietary Supplement)
Placebo Arm
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.
干预措施: Placebo (Dietary Supplement)