Legal

Last Updated: March 27, 2025

In Plain English: This document explains how the BAT Pill Protocol™ works, who’s responsible, how your data is handled, how your treatment and data are managed—including possible side effects—and how we support you through follow-ups, re-testing, and ongoing care. It’s designed to keep you safe, informed, and supported throughout your cognitive health journey.

1. Who’s Who in Your BATWatch Care

These BAT Testing™ Terms of Service (“Terms”) apply to all testing, coordination, clinical interpretation, and support services offered through the BATWatch™ platform.

These BAT Pill Protocol™ Terms of Service (“Terms”) apply to all services related to the coordination, prescribing, delivery, and follow-up of the BAT Pill Protocol™ offered through the BATWatch™ platform.

The term “BATWatch” refers collectively to a network of affiliated legal entities working together to deliver cognitive health solutions under the BATWatch™ brand. This includes:

• BATWatch Medical Entities – Licensed professional corporations (PCs) operating under BATWatch Medical, Inc. and its affiliated regional PCs. These entities are responsible for all clinical care, including medical evaluations, prescriptions, medication management, and decisions regarding eligibility or follow-up within the BAT Pill Protocol™.

• BATWatch Non-Medical Entities – Administrative and operational support organizations, including BATWatch, LLC and its regional Series MSOs. These entities provide logistical coordination, technology, data tracking, and patient-facing support unrelated to direct medical care.

• BATWatch Network Providers – Third-party, independent healthcare providers who participate in the BATWatch Network. These professionals may support the BAT Pill Protocol™ through referrals, eligibility review, or patient care services under their independent clinical judgment.

Throughout this document, “BATWatch” is used to refer collectively to these affiliated groups unless otherwise specified. References to clinical decisions, prescriptions, or treatment supervision specifically apply to licensed providers operating under BATWatch Medical entities or those participating in the BATWatch provider network (“BATWatch Network”).

These Terms apply only to the BAT Pill Protocol™ and related services. Testing, diagnostics, and general platform usage are governed under separate agreements.

2. Definitions

For clarity and consistency throughout this document, the following terms are used with the meanings defined below:

2.1 BAT Pill Protocol™ (BPP)

Refers to the structured, evidence-based treatment program offered by BATWatch for the purpose of reducing BAT Levels™ and supporting cognitive resilience. The protocol is supervised by licensed medical professionals and utilizes a pulsed dosing schedule of Sirolimus (Rapamycin) as its core therapeutic agent.

2.2 BAT Levels™

Short for Beta-Amyloid and Tau Levels. This term refers to key protein biomarkers associated with Alzheimer’s disease risk and progression. BAT Levels™ are identified and tracked through proprietary testing methods and are used to assess a patient’s cognitive risk profile.

2.3 BAT Pill™

A branded reference to the use of Sirolimus (Rapamycin) within the context of the BAT Pill Protocol™. This term refers specifically to the medication as prescribed and managed under the BATWatch clinical framework and does not apply to generic or unregulated formulations obtained outside the protocol.

2.4 BATWatch™

Refers to the collective network of affiliated entities that administer the BAT Pill Protocol™, including medical, non-medical, and operational support entities. BATWatch Medical entities are responsible for all clinical services; BATWatch, LLC and its affiliates provide non-clinical coordination, support, and infrastructure.

2.5 BATWatch Network

A network of licensed third-party healthcare providers who are authorized to refer patients, assist in clinical evaluation, or administer components of the BAT Pill Protocol™ in collaboration with BATWatch Medical entities.

2.6 Pulsed Dosing

A strategic medication schedule used in the BAT Pill Protocol™ to enhance benefits while minimizing risks. It refers to periodic administration cycles of Sirolimus, typically lasting 8 weeks, followed by reassessment of BAT Levels™.

2.7 Sirolimus (Rapamycin)

An FDA-approved mTOR inhibitor prescribed off-label within the BAT Pill Protocol™ to activate autophagy and support beta-amyloid clearance. The use of Sirolimus in this context is based on emerging research and is conducted under medical supervision.

2.8 Off-Label Use

Refers to the prescription of an FDA-approved drug for a use not formally approved by the FDA. Off-label prescribing is common in clinical practice and is permitted when supported by scientific evidence and clinical judgment.

2.9 Cognitive Resilience

The capacity of the brain to maintain function and resist neurodegeneration despite age-related or pathological changes. This is a core objective of the BAT Pill Protocol™.

2.10 BAT Level Index™

A proprietary scoring system developed by BATWatch to quantify cognitive risk based on biomarker data. The index allows for standardized assessment of patient progression and response to treatment.

2.11 Clearance Protocol™

A proprietary treatment algorithm within the BAT Pill Protocol™ designed to monitor, reduce, and maintain low BAT Levels™ using lab results, clinical criteria, and defined risk thresholds.

2.12 Mechanism Mapping™

A proprietary framework used to identify cellular or biochemical mechanisms contributing to elevated BAT Levels™, including inflammation, metabolic dysfunction, and impaired protein clearance.

2.13 Patient Portal

The secure online interface through which patients access their results, communicate with providers, and manage their participation in the BAT Pill Protocol™.

2.14 BATWatch Registry

An anonymized, centralized database of patient data collected through the BAT Pill Protocol™ and associated services. This registry supports ongoing quality improvement, scientific research, and precision risk modeling.

3. Your Results, Our Responsibilities

a) Data Custodian

BATWatch are the designated custodian of all patient medical records associated with BAT Testing™, including lab results, interpretation notes, and treatment recommendations. All records are maintained in compliance with HIPAA and applicable state or international data privacy laws.

b) Results Access

The BATWatch Platform provides patients secure access to their results and status updates. Authorized referring providers and participating providers in the BATWatch Network may also be granted secure access to patient results for coordination purposes, based on patient consent and data-sharing preferences.

c) Shared Access with Referring Providers

If a licensed third-party provider initiated the BAT Test™ order or is affiliated with the BATWatch Network, that provider may receive test results, risk stratification details, and care coordination summaries from BATWatch. However, treatment decisions and centralized care remain under the jurisdiction of BATWatch unless otherwise contracted.

d) Data Use for Research and Improvement

De-identified test results may be used for quality improvement, analytics, and research purposes, including registry contributions, in accordance with applicable privacy laws and BATWatch’s Privacy Policy. No personally identifiable information will be used without explicit patient consent.

e) Record Retention

BATWatch retains patient records, including testing data, risk scoring, and treatment logs, for a period required under federal and state recordkeeping regulations, or longer if required for clinical research purposes.

4. Treatment Overview

The BAT Pill Protocol™ is a targeted intervention program intended to address elevated BAT Levels™ identified through laboratory testing. The goal is to reduce pathological protein accumulation and support cognitive health before neurodegeneration begins. While early detection is essential, intervention plays a key role in risk mitigation.

The BAT Pill Protocol™ is designed to support cellular clearance processes, reduce inflammation, and optimize long-term brain resilience.

This protocol is offered as part of a broader cognitive health strategy and is not intended to diagnose, treat, or cure Alzheimer’s disease. All clinical decisions regarding treatment eligibility, dosing, and follow-up are made by licensed providers operating under BATWatch or the BATWatch Network.

5. Why Treat Elevated BAT Levels™?

Elevated BAT Levels™ may represent the earliest measurable biomarker associated with Alzheimer’s risk. Studies suggest beta-amyloid accumulation precedes symptoms by as much as two decades, and once downstream pathology (such as tau tangles) advances, neuronal damage becomes increasingly irreversible.

The BAT Pill Protocol™ was developed to:

• Intervene early—before cognitive decline begins.
• Address modifiable risk—by targeting BAT-related accumulation.
• Support cognitive longevity—through mechanisms grounded in cellular biology.

This approach reflects a growing body of research that supports the proactive management of brain aging and proteostasis dysfunction. While Alzheimer’s remains a complex and multifactorial condition, identifying and addressing BAT Levels™ early offers a potential path toward prevention.

6. Mechanism of Action – How the BAT Pill Protocol™ Works

The BAT Pill Protocol™ is built around the concept of autophagy enhancement—a cellular process responsible for clearing misfolded or toxic proteins. The protocol’s mechanism centers on mTOR inhibition, which has been shown in preclinical research to promote amyloid clearance and support brain resilience.

6.1 Core Mechanisms Supported by the BPP:

• Autophagy Activation: Supports natural cellular detox and clearance processes.
• Beta-Amyloid Clearance Support: Helps rebalance BA 42/40 ratios and reduce accumulation.
• Neuroinflammation Modulation: May reduce systemic inflammatory markers that accelerate cognitive decline.
• Mitochondrial Optimization: Enhances metabolic stability in neurons.

The BAT Pill Protocol™ utilizes a structured, time-bound dosing protocol intended to maximize these effects while ensuring safety under clinical supervision. Providers determine appropriateness and adjust based on patient-specific responses and post-treatment test results.

7. About Rapamycin (Sirolimus)

7.1 What Is It?

The core therapeutic agent used in the BAT Pill Protocol™ is Sirolimus (commonly known as Rapamycin), an FDA-approved medication with a decades-long track record for other indications. It is used off-label in the BPP under medical supervision and in accordance with applicable regulatory guidelines.

Rapamycin is a potent mTOR inhibitor known for its role in longevity, cellular repair, and autophagy regulation. Preclinical studies suggest potential benefits in reducing beta-amyloid accumulation and supporting cognitive health, though the drug is not approved for Alzheimer’s treatment.

7.2 Why Rapamycin Was Chosen

• Enhances Autophagy: Supports clearance of accumulated amyloid before tau formation can occur.
• Reduces Inflammatory Signals: May dampen cytokines and immune pathways linked to neurodegeneration.
• Improves Neuronal Resilience: Supports metabolic health and aging processes within the brain.

7.3 Dosing Strategy

The BAT Pill Protocol™ is delivered in pulsed cycles designed to balance efficacy with tolerability.

• Initial cycle: 8 weeks of supervised intervention.
• Post-cycle reassessment: Follow-up testing evaluates BAT Level™ response and informs next steps.

Dosing schedules may vary depending on updated clinical guidance or individual response to prior cycles, always under provider supervision. Treatment may be repeated based on individualized results and patient-provider discussion. All prescribing decisions are made by licensed medical professionals.

8. No Formulation Changes or Substitutions

The BAT Pill Protocol™ is a clinically guided treatment plan. It is not a standalone drug, nor a generalized supplement. It combines timing, dosage, patient monitoring, and post-treatment follow-up—all delivered under medical supervision by BATWatch-affiliated providers.
Patients may not substitute, alter, or self-administer alternative formulations of the protocol without prior approval from their prescribing provider.

This is not simply a “pill you can Google.” Even though Rapamycin is available generically, its use within the BAT Pill Protocol™ follows a specific cycle, dosing rhythm, and monitoring framework designed for cognitive health.

Changing the formulation, sourcing from unapproved channels, or modifying the schedule may invalidate clinical oversight, reduce effectiveness, and compromise patient safety.
All patients must agree to follow the protocol as prescribed in order to continue treatment under the BATWatch program.

9. Side Effects and Safety Monitoring

All prescription medications carry potential side effects. The BAT Pill Protocol™ is no exception. While our approach uses low-dose, pulsed Rapamycin to minimize risks, patients should be aware of the following possibilities:

9.1 Common Side Effects

Some patients may experience mild, temporary side effects during or after treatment. These may include:

• Lowered potassium levels
• Anemia or mild reductions in blood cell counts
• Elevated blood pressure or triglyceride levels
• Temporary changes in kidney function
• Constipation, diarrhea, or abdominal discomfort
• Joint or muscle pain
• Dizziness or headaches
• Fever or fatigue
• Mouth sores or nausea

These effects are typically mild and monitored closely by the care team during each treatment cycle.

9.2 More Serious Side Effects

Though rare, more serious risks may include:

• Lung toxicity (pneumonitis)
• Increased susceptibility to infections
• Heightened sensitivity to sunlight or UV exposure
• Potential increased risk of skin cancer without proper sun protection

Most of these risks have been observed in higher-dose, chronic use settings—such as in transplant medicine. The BAT Pill Protocol™ uses intermittent dosing and active clinical monitoring to reduce these risks.

Patients are encouraged to discuss all potential side effects and personal risk factors with their licensed healthcare provider prior to starting treatment.

10. Exclusion Criteria

Not every patient is a candidate for the BAT Pill Protocol™. The following medical factors may exclude a patient from receiving treatment to ensure safety and the highest standard of care. In some cases, eligibility may be reassessed after further clinical evaluation or follow-up testing. 

a) Immunosuppression & Infection Risk

• Active or Recent Infections: Includes tuberculosis, hepatitis B or C, HIV, or any known opportunistic infection.
• Frequent or Severe Infections: Recurrent respiratory, urinary tract, or skin infections may disqualify a patient.
• Immunocompromised Status: Includes patients post-transplant, undergoing chemotherapy, or on chronic immunosuppressants such as corticosteroids or biologics.
• Live Vaccines: Patients requiring live vaccinations during the protocol period may be excluded.

b) Active or Recent Cancer

• Ongoing Cancer Treatment: Patients actively receiving chemotherapy, immunotherapy, or radiation.
• Cancer Diagnosed Within the Last 5 Years: Excludes all except successfully treated non-melanoma skin cancers (e.g., basal cell carcinoma).
• Unresolved Skin Lesions: Suspicious or untreated lesions must be evaluated and cleared by a dermatologist.

c) Metabolic & Organ Function

• Uncontrolled Hyperlipidemia: LDL >190 mg/dL or triglycerides >500 mg/dL.
• Liver Dysfunction: Cirrhosis, active hepatitis, or liver enzymes (ALT/AST) >3× upper normal limit.
• Kidney Dysfunction: Chronic kidney disease Stage 4 or higher (eGFR <30 mL/min).
• Proteinuria: Urine protein excretion >300 mg/day.

d) Hematological Concerns

• Low Platelets or WBC: Platelet count <100,000/μL or WBC <3,000/μL.
• Anemia: Hemoglobin <10 g/dL.

e) Wound Healing & Surgery
• Recent Major Surgery: Within the past 4 weeks.
• Chronic Wounds: Includes diabetic ulcers, pressure sores, or other non-healing wounds.

f) Pulmonary Risk

• History of Lung Disease: Includes interstitial lung disease or pulmonary fibrosis.
• Unexplained Shortness of Breath: Must be fully evaluated before treatment.

g) Medication Conflicts

• Strong CYP3A4 Inhibitors: Concurrent use of ketoconazole, clarithromycin, ritonavir, or similar medications.
• Other mTOR Inhibitors: Concurrent use of sirolimus, everolimus, or comparable drugs.

h) Cardiovascular Risk
• Recent Cardiac Events: Unstable angina or myocardial infarction within the last 6 months.
• Severe Heart Failure: NYHA Class III or IV, or other forms of decompensated cardiac disease.

i) Neurological or Cognitive Barriers

• Advanced Dementia: Severe cognitive impairment that would prevent adherence to monitoring.
• Seizure History: Particularly if seizures are uncontrolled or medication-resistant.

j) UV Sensitivity & Skin Cancer Risk

• History of Melanoma: Personal or strong family history.
• Photosensitive Conditions: Such as lupus, porphyria, or similar autoimmune skin disorders.

k) Pregnancy & Fertility

• Pregnant or Breastfeeding: Not eligible due to limited safety data.
• Women of Childbearing Age Without Contraception: Effective contraception is required during treatment.

l) Psychological Considerations

• Severe Psychiatric Conditions: Includes psychosis, active suicidal ideation, or uncontrolled depression.
• Non-Adherence History: Patients with a known history of failing to follow medical guidance may be excluded.

m) Case-by-Case Review Criteria

Some conditions do not lead to automatic exclusion but require additional review:

• Mildly Elevated Lipids or Liver Enzymes: Patients may proceed under closer monitoring.
• History of Cancer >5 Years Ago: May proceed if fully in remission and treatment-free.
• Older Adults with Comorbidities: May be considered if overall health is stable and risks are manageable.

Patients falling under these special considerations will be reviewed by a BATWatch-affiliated provider to determine eligibility and appropriate monitoring strategy.

11. Disclaimers and Risk Acknowledgments

By enrolling in the BAT Pill Protocol™, you acknowledge that this program represents an innovative approach to Alzheimer’s prevention and cognitive health management—grounded in evolving clinical research.

As a participant, you understand that:

a) The BAT Pill Protocol™ is an off-label, evidence-based treatment program designed to reduce BAT Levels™ and lower the risk of tau-driven neurodegeneration. The protocol uses Sirolimus (Rapamycin), an FDA-approved drug for other conditions, administered in pulsed cycles.

b) Off-Label Use Disclosure: The use of Sirolimus in this context is considered “off-label.” Off-label prescribing is a standard and legally permissible medical practice when supported by scientific literature and physician judgment. It is widely used across specialties such as oncology, cardiology, and pediatrics.

c) Research-Based Protocol: The BAT Pill Protocol™ is based on peer-reviewed research, clinical insights, and established principles in neuroprotection and autophagy activation.

While the goal is to lower BAT Levels™ and mitigate long-term cognitive risk, BATWatch cannot and does not guarantee specific outcomes.

d) Not a Cure for Alzheimer’s Disease: This protocol is designed to modify risk biomarkers associated with Alzheimer’s, but it is not a cure or guaranteed prevention for Alzheimer’s or any other neurodegenerative condition.

12. Release of Liability Specific to the BAT Pill Protocol™

By participating in the BAT Pill Protocol™, you voluntarily assume responsibility for potential risks, and you agree to release BATWatch and its affiliated entities from liability for claims arising from, but not limited to:

a) Individual Variability: Differences in how your body responds to treatment or unexpected results.
b) Medical Complexity: The presence of other diagnosed or undiagnosed conditions.
c) Past Treatments: The influence of other medications or historical therapies.
d) Adherence: Results affected by your level of compliance with the prescribed treatment plan.
e) Comorbidities: Outcomes complicated by rare, complex, or unmanaged conditions.
f) Aggravation of Pre-Existing Conditions: Including conditions not previously identified.
g) Unforeseeable Events: Medical incidents that could not be predicted.
h) Emotional or Psychological Impact: Anxiety, distress, or other emotional responses tied to the treatment experience.
i) Drug Reactions: Allergic or adverse responses to Rapamycin or any related compounds.
j) Adjustment Period: Side effects or discomfort during initial or transition phases.
k) Relationship Effects: Strain or emotional impact on family or interpersonal relationships.
l) Other Unintended Consequences: Any outcome not anticipated by BATWatch or your provider.

You further agree that this Release of Liability applies regardless of any claims of negligence or error by BATWatch or its representatives, except where prohibited by law.

13. Assumption of Risk

By participating in the BAT Pill Protocol™, you affirm that:

a) Voluntary Participation: You are enrolling willingly and understand the purpose, structure, and nature of the treatment.

b) Informed Consent: You have discussed the risks, benefits, and alternatives with your provider and had the opportunity to ask questions.

c) Risk Acceptance: You acknowledge that no outcomes are guaranteed, and results may vary based on individual biology, medical history, and treatment adherence.

14. Indemnification Acknowledgment

Your participation in the BAT Pill Protocol™ is subject to the indemnification provisions outlined in the broader BATWatch Terms of Service. By continuing treatment, you agree to indemnify and hold harmless BATWatch and all associated entities from any claims, losses, or liabilities related to your participation, as described in those terms.

15. Contact and Emergency Procedures

If you experience side effects or have medical concerns during your treatment:

a) Mild Side Effects: Contact your assigned BATWatch provider through your patient portal or use the designated contact number provided at enrollment.

b) Emergency Situations: If you experience severe symptoms, dial 911 or visit the nearest emergency facility immediately.

c) Support Line: For urgent, non-emergency issues, call the BATWatch Support Line at 202-681-1274, available Monday–Friday, 9am to 5pm PST.

d) Patient Safety Commitment: BATWatch encourages prompt reporting of all side effects or concerns so we can ensure proper follow-up and support.

16. Right to Discontinue or Terminate Treatment

BATWatch reserves the right to discontinue or pause your participation in the BAT Pill Protocol™ under the following conditions:

a) Medical Safety Concerns: Your provider determines that continuation poses a health risk.

b) Non-Compliance: Failure to attend follow-ups, complete required labs, or adhere to dosing protocols.

c) Emerging Clinical Evidence: New scientific findings suggest that the protocol is no longer appropriate for your profile.

You may also choose to discontinue at any time. However, we strongly recommend that you consult with your provider before stopping treatment to ensure a safe and informed transition.

17. Patient Informed Consent

By participating in the BAT Pill Protocol™, you acknowledge and confirm the following:

a) Off-Label Use Acknowledgment

You understand that the BAT Pill Protocol™ uses Sirolimus (Rapamycin) off-label. This is a widely recognized and evidence-based practice within the medical community when supported by clinical judgment and research.

b) Risks and Benefits

You have discussed the potential risks, benefits, and alternatives of the BAT Pill Protocol™ with your healthcare provider.

c) Questions and Understanding

You have had the opportunity to ask questions about the treatment and have received answers to your satisfaction.

d) No Guarantees

You acknowledge that BATWatch and its providers have not made any promises or guarantees regarding specific outcomes or results.

e) Voluntary Participation

You are enrolling voluntarily, with full understanding of the protocol and its intent, and consent to participate in the BAT Pill Protocol™ as part of your personal cognitive health plan.

18. Intellectual Property and Proprietary Rights

All testing methodologies, panel names, sequencing logic, scoring systems (including the BAT Level Index™), and branded protocol terminology (e.g., Clearance Protocol™, BAT Pill™, ClearCheck™, Mechanism Mapping™, Contribution Factor Mapping™) are proprietary to BATWatch. These materials are protected under applicable intellectual property laws, including trademark, trade secret, and copyright protections.

No part of the BATWatch Protocol™, including test sequencing or decision logic, may be replicated, reverse-engineered, or redistributed without written authorization from BATWatch. Any unauthorized use of BATWatch’s intellectual property may result in legal action.

All materials provided through the BATWatch Platform, including visual representations, summaries, and guidance documents, are for personal and clinical use only and may not be used for commercial purposes without express written permission.

19. Acceptance of Terms

By participating in BAT Pill Protocol™ or engaging with any services provided through BATWatch or its authorized affiliates, you acknowledge that you have read, understood, and agreed to these Terms of Service.

These Terms may be updated periodically. The latest version will always be available at batlevels.com/legal. Continued participation in BAT Pill Protocol™ services constitutes ongoing agreement with any updates made.