Boosting the Brain - Developing Percepta® with Cat’s Claw from the Amazon Rain Forest

Percepta® is a patent-protected brain health natural dietary supplement (active ingredients, PTI-00703® Cat’s claw and MemorTea® - a specific oolong tea extract). Cerebrum DAO will be supporting the development of near- and long-term solutions for targeting cognitive decline, memory loss and neurodegenerative diseases.

The global market for brain health supplements is over $8.6b - most if not all lack clinical evidence to support efficacy. Percepta® has robust patent protection and highly promising research results. Leaders in this category generate annual revenues of $200m or more without evidence to support efficacy in humans.

Percepta has the potential to be the category leader in this fast growing $8.6b market with human evidence to support outcomes and the funding of future studies that could lead to FDA botanical drug status which is the ultimate goal.

This IPT represents a world’s first tokenization of a robust patent portfolio and a world’s first tokenized crowdsale for a clinical evidence study.

Success with this study can lead to future trials that create the potential for FDA botanical drug approval, unlocking revenue potential above the current $8.6b market via potential prescriptions and insurance coverage - but most importantly broad access to improve brain health globally.

Scientific American recently coined Alzheimer’s as “The Ten Trillion Dollar Disease”. According to the U.N. World Social Report 2023, the number of people aged 65 and older is expected to reach 1.6 billion by 2050, up from 761 million in 2021.

As more and more people live longer, Alzheimer’s and other forms of dementia become a grave threat, and memory loss impacts the quality of our longer lives. The number of people with Alzheimer’s is expected to reach 150 million by 2050. Yet today, we still lack effective therapeutics against the disease and proactive preventions to preserve and protect our brains and memory against decline with aging. We must develop proactive solutions that have evidence of efficacy to change the trajectory of these tragic numbers.

Percepta®

Percepta® and its ingredients have data from transgenic mouse models and in vitro experiments supporting its effectiveness against Alzheimer’s pathology (i.e., amyloid plaques, neurofibrillary tangles, and neuroinflammation). Emerging human clinical data shows that Percepta® may support memory improvement in patients with memory loss, mild cognitive impairment (MCI), and early Alzheimer’s.

In a comparative study of major memory-support dietary supplements, Percepta® ranked significantly higher than 19 other popular supplements, including:

• Prevagen®
• Neuriva Plus
• Alpha Brain (owned by Onnit Labs and acquired by Unilever for an estimated value of $400M–$500M).

Results:

• In vitro results showed that Percepta® reduces Aβ 1–42 fibrils by 69.6% in comparison to Alpha Brain by 34.9%.
• In the same study, tau paired helical/straight filaments saw an 85.7% reduction from Percepta® versus Neuriva Plus (57.9%).

The results were published in the prestigious medical journal, Nature - Scientific Reports, in 2019.

Percepta® Overview

Percepta® has been on the market as a memory-support dietary supplement but currently has no clinical data in humans supporting the pre-clinical findings. In vitro and clinical studies will be performed to measure the efficacy of Percepta® in humans.

Percepta® is based on the PTI-777 extract from Uncaria tomentosa (i.e., cat’s claw), which has been shown to cross the blood-brain barrier and reduce beta-amyloid plaque load and number in rats and/or mice (several studies). Proanthocyanidin B2 extracted from PTI-777 markedly reduced brain plaque load, improved hippocampus-dependent memory, and decreased inflammation in mice [Snow (2019)]. Outside of Percepta®, two studies have shown improvement in spatial memory in rodents after administration of Uncaria tomentosa (cat’s claw).

Beyond Uncaria tomentosa, there is a relatively large set of literature on the role of polyphenols (including proanthocyanidins) studied using in-vivo models of Alzheimer’s.

The Project

The primary study will be a double-blinded randomized controlled decentralized trial that investigates the effect of Percepta® on memory. The primary endpoint will include the Montreal Cognitive Assessment (MoCA) to measure memory and cognitive metrics.

In the decentralized trial design, wearable sensor devices (e.g., Oura, Apple Watch) will capture lifestyle activity data of the test subjects, including activity, heart rate, and sleep metrics. The BrainHealth® Index (BHI) will be included as an exploratory endpoint. The BHI measures overall brain performance and is based on a proprietary algorithm from more than 20 established assessments.

It is planned to include the BHI into future product partnerships at Cerebrum DAO and will be valuable in the development of the Cerebrum DAO product ecosystem (including Percepta®).

The study will be managed by Cerebrum DAO with support by Reputable Health using their decentralized trial platform, enabling study design, subject recruitment, and results. The study will be reviewed by an independent review board (IRB).

Grand View Research determined the global brain health supplements market was valued at $8.6 billion in 2022 and is expected to grow at a CAGR of 13.3% from 2023 to 2030. The growth is attributed to rising awareness of issues, such as lack of attention, focus, declining memory, anxiety, and depression. The increasing adoption of natural and herbal health products is anticipated to fuel the industry's growth over the forecast period.

Existing solutions lack evidence to support true outcomes in humans. Prevagen is a leading memory support supplement with annual revenues that exceed $200 million per year, yet the product is promoted largely with anecdotal quotes from users.

IP Portfolio and Commercial Potential

The IP portfolio licensed herein from Cognitive Clarity is grounded in science, has strong global human safety evidence, has been defended legally, and has strong laboratory results in animal and human cell models.

Upon proving results in human studies, this IP portfolio has the potential to be the leader in the brain health natural product segment and can provide a pathway to US FDA botanical drug approval.

The commercial potential with positive results from this study could capture a material position in the existing market, including a leadership spot over Prevagen (Quincy Biosciences) and Neuriva (Schiff Vitamins). Further development of the IP into an FDA botanical drug designation could become a blockbuster.

Intellectual Property

The IP licensed herein has already been successfully litigated against Alpha Brain (Onnit Labs), a supplement that included the IP in its formulation and was later acquired by Unilever for $400 million–$500 million.