TLDR

Cognitive Clarity Inc. is the producer of Percepta®, a patent-protected brain health dietary supplement (active ingredients, PTI-00703® and MemorTea®). This proposal is to approve raising $80,000 in funding for an expansion of the human clinical trial being conducted by Cerebrum on the effect of brain health supplement products on humans to include a pTau-217 blood biomarker. Adding this biomarker can provide strong, objective evidence of Percepta’s ability to positively impact the core mechanisms of memory loss and neurodegeneration, strengthening its position in the market and boosting sales. The underlying $CLAW IP-NFT currently captures a 20 % royalty on all revenues of Percepta® plus a higher royalty rate on future international expansion to be negotiated by new market.

Summary Deal Analysis

We are seeking community approval to raise $80,000 to fund a pTau217 blood biomarker as a new endpoint for the originally proposed human clinical trial for Percepta.

This funding increase aims to improve upon the original study design by the inclusion of the pTau-217 blood biomarker and advance our community’s understanding of mitigating early memory loss, using a safe and commercially available supplement. pTau-217 has emerged as one of the most clinically actionable Alzheimer’s disease biomarkers to date—delivering diagnostic accuracy comparable to traditional CSF/PET measures, while also offering prognostic and therapeutic-response insights from a simple blood sample.

Bio Protocol has agreed to preliminary terms to fund this study expansion based on the merits of the evidence we supplied to them and their community and the potential additional positive outcomes that can be achieved for this project.

The terms of the proposed financing are as follows:

• $80,000 of total funding
• 25% of the funding ($20,000) will be in exchange for $CLAW tokens issued at the $USD price of $CLAW at the time of funding
• 75% of the funding will be in the form of a convertible loan with the following mechanics:
• 4.25% simple annual interest rate
• 24 month term
• Payable in advance in whole or in parts
• Upon Term, the remaining unpaid principal and interest shall auto-convert into $CLAW tokens at the USD price of $CLAW at the time the loan funded

Note that this funding will result in immediate dilution to CLAW token holders in the amount of $20,000 divided by the FDV of $CLAW plus $20,000 (for sake of example, the current FDV of $CLAW is ~$550,000 - so the dilution in this example would be $20,000 / $570,000 = 3.5%). Approval would mean that this dilution would be more than off-set by the value of including the pTau217 biomarker in the current study design.

Cerebrum DAO Team

Cerebrum DAO Lead Investigator: Dr. Mark Melnykowycz Project Team: Maryna Polyakova, Brian Magierski, Peter Groenen

Cognitive Clarity Team

CEO, Founder: Dr. Alan Snow

Clinical Trial Design

A human clinical trial has been designed to assess the effect of Percepta on cognitive performance.The decentralized clinical trial will focus on the safety and efficacy of Percepta in adults with self-reported Mild Cognitive Impairment (MCI). One hundred fifty-four participants aged 40 to 85 with self-reported MCI will be recruited and randomized 1:1 into either the Percepta or placebo group. The study will be conducted remotely, with participants receiving supplements at home and completing assessments via a mobile application and wearable devices (Oura Ring). Cognitive performance will be measured using the digital Montreal Cognitive Assessment (MoCA), wearable biomarker metrics (sleep quality, heart rate variability), and the Brain Health Index (BHI). The primary objective is to determine if Percepta supplementation leads to significant improvements in cognitive performance as measured by the digital MoCA. Secondary objectives include improvements in wearable device biomarker metrics and BHI scores. Exploratory objectives may involve assessing blood biomarkers. Endpoints will be assessed at baseline, 3 months, and 6 months, with potential extensions to 9 and 12 months.

pTau-217 Blood Biomarker

To enhance the strength of evidence in the clinical trial it is proposed to include the pTau-217 blood biomarker in the study.

The promise of pTau-217 as a surrogate endpoint for the development of novel treatments in Alzheimer’s disease is quite compelling.

It’s a “smoke alarm” for Alzheimer’s biology—years before the fire spreads.

The level of pTau-217 in a single tube of blood starts to rise long before noticeable memory trouble and even 15-20 years before a formal Alzheimer’s diagnosis. Detecting that rise in people who only have mild forgetfulness tells researchers the disease process is already smouldering.

You get a clear yes/no answer without spinal taps or brain scans.

In head-to-head studies, the blood test matches the accuracy of expensive PET scans or spinal-fluid tests for spotting Alzheimer’s changes—even at the MCI stage—so participants avoid invasive procedures and sites save money.

It predicts who is most likely to decline—and how fast.

Higher starting pTau-217 makes someone with MCI far more likely to slide into dementia within the next couple of years, letting a trial focus on the people who will actually show a change while the study is running.

The number moves quickly when a treatment is working.

In recent anti-tau and anti-amyloid trials, pTau-217 dropped in the blood months before traditional memory tests budged, providing an early “thumbs up” (or down) on whether the drug is hitting its target.

It shrinks study size and cost.

Because you can pre-screen with a simple blood draw and use a fast-changing lab number as the main outcome, fewer people need to enroll and they can be followed for a shorter time—speeding answers and lowering budgets.

If amyloid and tau pathologies are reduced during the study, blood plasma p-tau levels should fall. Amyloid plaque load is thought to drive tau hyperphosphorylation; removing plaques can thus downstream reduce p-tau production. The pTau-217 test can be administered with sample collection at home, making it ideal for the current decentralized clinical trial. Testing will require sample kits, shipping and logistics of samples to Quanterix for assay analysis.

Opportunity

The brain and memory health supplement market is a massive, growing industry, projected to reach over $23 billion globally by 2030. However, it lacks products with strong, direct human evidence. This study expansion presents a major opportunity as outlined below.

Market Differentiation

With successful trial results validated by biomarkers, Percepta® would be one of the only supplements on the market with proven efficacy in humans and a strong patent portfolio to protect it.

Increased Commercial Value

Objective proof of efficacy would make Percepta® a highly attractive acquisition target for major consumer health companies like Unilever, Nestle, or P&G, with a potential exit valuation between $50 to $100 million or higher (Such as Onnits acquisition by Unilever) https://www.unilever.com/news/press-and-media/press-releases/2021/unilever-to-acquire-onnit/

Drug Development Pathway

Positive results would support new, stronger marketing claims and could pave the way for an FDA pathway for botanical drug status, a potential game-changer in the field.

Community and Returns

The IP is tokenized as the $CLAW token, and Cerebrum DAO receives a 20% royalty on all global sales, providing a direct economic benefit to the DAO and its members from the project’s success.

Patent Formulation

The $CLAW formulation is patented. Chief Scientist, Dr. Alan Snow, previously secured a 7-figure cash settlement on legal action against Joe Rogan’s AlphaBrain that used the $CLAW formulation without a license.

Scalable Production

Existing supply chains can produce 3M units per year. Currently a one month supply sells for $60. This yields $180M a year revenue potential without any major supply chain upgrades.

Conclusion

By approving this PDP-2, you are authorizing the project team to accept and close the proposed funding from Bio Protocol for the pTau-217 biomarker expansion within the terms outlined above. Rejecting this proposal will mean that the current human trial study will proceed as originally planned but without the pTau-217 biomarker as a clinical endpoint.