Legal

Last Updated: February 17, 2025

1. Introduction

This BAT Pill Protocol (BPP) Terms of Service (“BPP Terms”) outlines the treatment methodology, usage guidelines, and patient eligibility criteria for the BPP, a proprietary treatment program provided by Silver House Healthcare, LLC (“Silver House”) through the BATWatch Protocol, a program offered by Silver House. (“BATWatch”).

These Terms apply exclusively to the BAT Pill Protocol. General service terms, including indemnification, arbitration, and dispute resolution, are covered separately under the BATWatch Terms of Service.

2. Roles and Responsibilities

a) Silver House: The exclusive provider of all BAT Pill Protocol and patient care. Silver House is responsible for all healthcare services provided under the BATWatch program.

b) BATWatch: A digital platform and patient engagement program operated by Silver House to support appointment scheduling, results delivery, and educational resources. BATWatch is not a healthcare provider. All medical decisions are made by Silver House or licensed providers affiliated with Silver House.

3. Data and Results Ownership

a) Data Custodian: Silver House maintains all medical records, including BAT Treatment results, in compliance with HIPAA and applicable state laws.

b) Results Access: BATWatch serves as a secure portal for accessing results, but Silver House retains sole authority over medical record management.

c) Data Sharing: Results may be shared with your designated healthcare provider and used by Silver House for quality improvement and research purposes, in accordance with our Privacy Policy.

d) Record Retention: Silver House retains your test results as required under federal and state healthcare recordkeeping laws.

4. Treatment

While early BAT Level detection is essential, the next step is just as critical: lowering BAT Levels before tau accumulation and neurodegeneration begin. The BPP is designed as a targeted intervention strategy to clear toxic amyloid buildup, reduce neuroinflammation, and optimize long-term cognitive resilience.

5. Why Treat BAT Levels?

Many providers and patients may ask: “If Alzheimer’s isn’t fully curable, why treat BA Levels early?”

The answer is simple: beta-amyloid accumulation precedes cognitive symptoms as much as 20 years, and once tau pathology progresses, neuronal damage becomes irreversible.

Clearing BAT Levels early prevents tau formation.

Lowering BA Levels is the only proven modifiable risk factor for Alzheimer’s prevention.

Treatment is safe, cost-effective, and widely available.

The goal of the BPP is to intervene at the earliest possible stage, mitigating risk long before symptoms emerge.

6. Mechanism of Action: How the BAT Pill Works

The BPP is designed around autophagy activation, a natural cellular process that clears toxic protein buildup. The key mechanism behind this is mTOR inhibition, which enhances the body’s ability to remove beta-amyloid and maintain brain health.

6.1 Core Mechanisms of Action:

Autophagy Activation: Enhances the brain’s ability to clear misfolded proteins.

Beta-Amyloid Clearance: Directly reduces BA 42/40 ratio and neurotoxic accumulation.

Neuroinflammation Reduction: Lowers systemic inflammation markers that contribute to cognitive decline.

Mitochondrial Function Optimization: Supports cellular energy metabolism, critical for brain resilience.

The protocol uses a structured, evidence-based dosing schedule to maximize benefits while ensuring safety.

7. Rapamycin: The Core of the BPP

7.1 What is Rapamycin?

Rapamycin is an mTOR inhibitor that has been extensively studied for longevity, cellular repair, and neuroprotection.

It has been shown to reduce beta-amyloid levels in preclinical models and is widely considered a promising off-label intervention for Alzheimer’s risk reduction.

Its safety profile is well established, as it is FDA-approved for other conditions and has been used in humans for decades.

7.2 Why Rapamycin Works for BAT Levels

Enhances Autophagy: Breaks down accumulated beta-amyloid before it leads to tau formation.

Reduces Neuroinflammation: Lowers cytokine and immune activation associated with Alzheimer’s.

Delays Cellular Aging: Improves metabolic resilience in neurons, preventing damage over time.

Dosing Strategy:

Administered in pulsed cycles to optimize benefits while avoiding side effects.

Initial cycle: 8 weeks of intervention with follow-up testing.

Reassessment of BAT Levels post-treatment determines next steps.

8. Monitoring & Follow-Up Testing

Patients undergoing the BPP are closely monitored:

Post-Treatment BA & T Testing: To confirm beta-amyloid clearance.

Mechanism Panel Reassessment: To ensure all modifiable risk factors are addressed.

Annual BAT Testing: To prevent re-accumulation and ensure long-term success.

9. Defining Target Levels for Beta-Amyloid Reduction

The goal of the BPP is to lower beta-amyloid accumulation to a level where further neurodegenerative risk is minimized. Based on clinical research and biomarker-based risk assessment, we define the following target thresholds:

Primary Target: Achieve BA Ratio ≥ 0.170 (above known Alzheimer’s risk range).

Optimal Target: Lower BA to the lowest safe threshold without inducing compensatory effects.

Treatment Adjustment Threshold: If BA does not decrease sufficiently, additional cycles are required.

pTau is the critical decision point:

If positive, the focus shifts from prevention to management.

If negative, we continue targeting BA for prevention, ensuring early intervention before irreversible damage occurs.

T Testing is required before starting treatment to determine whether beta-amyloid accumulation has triggered neurodegeneration. If pTau is elevated, intervention strategies may need to be modified.

10. Structure & Treatment Cycles

The protocol follows a structured, cyclical treatment process with testing checkpoints:

Cycle Duration: 8 weeks of rapamycin treatment

Testing & Monitoring: BA & T Testing at Week 13

Decision Point: Determine whether another cycle is needed

This approach allows for a full BAT reduction cycle, followed by a 5-week clearance window, before re-measuring biomarker levels.

11. Sequential Treatment Approach – When to Continue Cycles

First BAT Pill Cycle: Measure BA & T at Week 13

If BA Levels remain elevated, repeat a second BAT Pill Cycle immediately (no waiting period required).

If BA is reduced but not fully optimized, continue treatment cycles until target levels are reached.

Not all patients will require multiple cycles—quarterly testing and treatment are only continued if BA Levels remain above the target threshold. Once BA Levels are sufficiently reduced and T Test remains negative, patients transition to annual monitoring.

Patients remain in quarterly (every 3 months) testing and treatment cycles until risk is minimized.

This accelerated 3-month treatment cycle ensures that patients stay ahead of neurodegeneration risk by aggressively lowering beta-amyloid before tau accumulation begins. Once BAT Levels are at below desired threshold, patients go back into annual testing for follow-up.

12. When Do We Stop Treatment?

Treatment cycles continue until one of the following conditions is met:

For Preclinical (Early) Patients:
• BA Ratio reaches ≥0.170 (or lowest achievable level)
• T Test remains negative (no signs of neurodegeneration)
• No persistent mechanisms driving re-accumulation (MP re-test confirms resolution of risk factors)
• Transition to annual monitoring

APOE4 carriers may require extended treatment cycles, as their impaired lipid transport function leads to faster BA re-accumulation. These patients may need longer-term Rapamycin strategies or additional metabolic support interventions to maintain low BA Levels.

For Late-Stage or Persistent T Patients:
• BA Levels reduced, but T remains elevated
• Continued treatment cycles to slow further neurodegeneration
• Transition to extended monitoring and alternative supportive interventions

13. Long-Term Monitoring

The BPP is not just about reducing beta-amyloid levels—it’s about keeping them low and preventing future accumulation. While early intervention with the BPP is the first priority, long-term monitoring and targeted interventions ensure that levels stay controlled, and tau accumulation never begins.

Once BA Levels have been successfully lowered and stabilized, additional supportive interventions may be introduced to minimize future accumulation based on individual mechanisms identified in MP testing.

We don’t just treat BA Levels once—we maintain control long-term. The “Watch” in BATWatch ensures that patients are monitored, and any early warning signs of BA accumulation are addressed before they turn into irreversible neurodegeneration. If BA Levels begin rising again, the patient may re-enter the treatment cycle before tau accumulation occurs.

14. No Formulation Changes

Referring to treatments such as the BAT Pill is intended to simplify communication and enhance public understanding of their potential use in targeting BAT Levels. This does not imply any changes to the formulation or regulatory status of these treatments. All uses of any medication, including off-label uses, should be discussed with a licensed healthcare provider. For more detailed information, ongoing updates, and participation in clinical studies, please refer to our educational resources and study enrollment sections on our website.

15. Side Effects

Certain autophagy-related interventions that we use in our BPP have well-documented safety profiles, although primarily prescribed under strict medical supervision due to their range of possible side effects.

15.1 Common Side Effects

Common side effects from certain autophagy-related interventions may include lowered potassium levels, anemia, reduced blood platelets, elevated blood pressure, diminished kidney function, and increased triglyceride levels. Patients might also experience constipation, joint and muscle pain, dizziness, fever, headaches, nausea, diarrhea, mouth sores, and abdominal discomfort.

15.2 More Serious Side Effects

More serious but rare side effects include lung toxicity and an elevated risk of infections, particularly in transplant patients. The FDA notes that when using certain autophagy-related interventions there may be a potential heightened sensitivity to sunlight and UV radiation, which may increase the risk of skin cancers without high SPF sunscreen or other protective measures. It is crucial for patients considering this treatment to discuss these risks thoroughly with their healthcare provider to ensure comprehensive understanding and appropriate management of their condition.

16. Exclusion Criteria

a) Immunosuppression & Infection Risks

• Active or Recent Infections: Tuberculosis, hepatitis B/C, HIV, or any opportunistic infection.
• History of Frequent or Severe Infections: Recurrent respiratory, urinary tract, or skin infections.
• Immunocompromised Conditions: Post-transplant patients, current chemotherapy, or chronic use of immunosuppressants (e.g., corticosteroids, biologics).
• Vaccination Concerns: Patients who need live vaccines within the treatment period.

b) Active or Recent Cancer

• Current Cancer Diagnosis or Undergoing Treatment:Exclude patients actively receiving chemotherapy, radiation, or immunotherapy.
• History of Cancer within the Last 5 Years: Except for non-melanoma skin cancers (e.g., basal cell carcinoma) that have been treated and cleared.
• Untreated or Suspicious Skin Lesions: Until evaluated and cleared by a dermatologist.

c) Metabolic & Organ Function Concerns

• Uncontrolled Hyperlipidemia:LDL cholesterol >190 mg/dL or triglycerides >500 mg/dL.
• Severe Liver Disease: Cirrhosis, active hepatitis, or ALT/AST >3x the upper limit of normal.
• Kidney Disease: Chronic kidney disease Stage 4 or higher (eGFR <30 mL/min).
• Proteinuria: Significant protein in urine (>300 mg/day).

d) Hematological Concerns

• Thrombocytopenia or Leukopenia:Platelet count <100,000/μL or white blood cell count <3,000/μL.
• Anemia: Hemoglobin <10 g/dL.

e) Wound Healing Concerns

• Recent Major Surgery:Surgery within the past 4 weeks or planned major surgery during the protocol period.
• Chronic Non-Healing Wounds: Diabetic ulcers, pressure sores, or other chronic wound conditions.

f) Pulmonary Concerns

• History of Interstitial Lung Disease or Pulmonary Fibrosis:Rapamycin, in rare cases, has been linked to lung issues at high doses.
• Unexplained Shortness of Breath: Until fully evaluated.

g) Drug Interactions

• Concurrent Use of Strong CYP3A4 Inhibitors:Ketoconazole, clarithromycin, ritonavir, or similar medications.
• Concurrent Use of mTOR Inhibitors: Everolimus, sirolimus, or similar drugs.

h) Cardiovascular Concerns

• Unstable Angina or Recent Myocardial Infarction:Within the last 6 months.
• Severe Congestive Heart Failure (NYHA Class III or IV): Or other decompensated heart conditions.

i) Neurological & Cognitive Concerns

• Severe Cognitive Impairment:Advanced dementia where compliance with monitoring is unlikely.
• History of Seizures: Particularly uncontrolled or poorly managed.

j) Skin Cancer & UV Sensitivity Risks

• Personal or Family History of Melanoma
• Photosensitivity Disorders:Lupus, porphyria, or similar conditions.

k) Pregnancy & Fertility Concerns

• Pregnant or Breastfeeding Women:Excluded due to insufficient safety data.
• Women of Childbearing Age Not Using Contraception: Effective contraception must be used during the protocol.

l) Psychological Concerns

• Uncontrolled Mental Health Disorders:Severe depression, psychosis, or active suicidal ideation.
• Noncompliance History: Patients with a history of poor adherence to medical protocols.

Special Considerations (Case-by-Case Evaluation)

m) Mild Hyperlipidemia or Elevated Liver Enzymes:

• Patients with borderline lab results may be considered if they’re otherwise healthy, with close monitoring.

n) Older Adults with Comorbidities:

• Evaluate on a case-by-case basis if risks are manageable.

o) Patients with a History of Cancer >5 Years Ago:

• Can be considered if cancer-free and with no ongoing treatments.

17. Disclaimers and Risk Acknowledgments 

By enrolling in the BATWatch™ Program, you acknowledge that BPP represents an innovative approache to Alzheimer’s prevention and cognitive health management, grounded in evolving clinical research. As a participant, you understand that: a) The BPP is an off-label, evidence-based treatment program designed to reduce BAT Levels and lower the risk of tau-driven neurodegeneration. The BPP uses Sirolimus (Rapamycin), an FDA-approved medication for other conditions, administered in pulsed cycles. b) Off-Label Use Disclosure: The BPP utilizes Sirolimus off-label, which is a standard and legally permissible medical practice when supported by scientific evidence. Off-label prescribing is common in fields such as oncology, cardiology, and pediatrics, and it is recognized as ethical when it prioritizes patient safety and transparency. c) Research-Based Protocol: The BPP is based on peer-reviewed studies, extensive clinical experience, and established principles in neuroprotection and autophagy activation. However, while the treatment aims to reduce BAT Levels and associated risks, Silver House cannot guarantee specific health outcomes. d) Not a Cure for Alzheimer’s Disease: The BAT Pill Protocol is designed to lower biomarkers associated with Alzheimer’s risk. It is not a cure or guaranteed preventative measure against Alzheimer’s or any other disease.
18. Release of Liability specific to BPP: This release includes, but is not limited to, any claims arising from: a) Individual Variability: Differences in treatment responses, outcomes, or unexpected reactions. b) Diagnosis Specifics: The impact of pre-existing conditions, comorbidities, or undiagnosed conditions. c) Treatment History: Prior therapies, medical conditions, or medications that may influence outcomes. d) Adherence to Therapy: Variations in results due to your compliance with prescribed protocols. e) Complex Needs: Outcomes affected by unique health complexities or rare conditions. f) Pre-existing Conditions: Aggravation or interaction with existing medical conditions. g) Unpredictable Incidents: Unexpected medical events not foreseeable at the time of treatment. h) Emotional Stress and Distress: Including anxiety, frustration, or psychological discomfort related to treatment outcomes or experiences. i) Medication Reactions: Adverse or allergic reactions to prescribed medications, including but not limited to, Rapamycin. j) Adjustment Period: Side effects or discomfort during the initial phases of treatment. k) Interpersonal Dynamics: Impacts on relationships or emotional well-being resulting from treatment experiences. l) Unintended Consequences: Any other unexpected or unintended outcomes arising from participation in the BPP. You further agree that this Release of Liability applies regardless of any allegations of ordinary negligence or other fault by Silver House or its representatives, except where prohibited by applicable law.

19. Assumption of Risk

By participating in the BATWatch™ Program and undergoing the BPP, You confirm that: a) Voluntary Participation: You are participating voluntarily, with full understanding of the nature and purpose of the BAT Tests™ and BAT Pill™ treatments. b) Informed Consent: You have reviewed the potential risks, benefits, and alternatives with your healthcare provider and had an opportunity to ask questions. c) Acceptance of Risks: You accept that outcomes are not guaranteed and may vary based on individual factors, including medical history, treatment response, and adherence to therapy.

20. Indemnification Acknowledgment

Your participation in the BAT Pill Protocol (BPP) is subject to the indemnification terms outlined in the BATWatch Terms of Service, which govern all services provided under the BATWatch Program. By participating in the BPP, you acknowledge and agree that those indemnification terms apply to your participation in this treatment program. This means that you agree to indemnify and hold harmless the Released Parties from any claims, losses, or liabilities arising from your participation in the BPP, as further described in the BATWatch Terms of Service.

21. Contact and Emergency Procedures

In the event of side effects or medical concerns during your participation in the BAT Pill Protocol: a) Routine Side Effects: Contact your Silver House provider through the patient portal or designated contact number provided at enrollment. b) Severe or Emergency Side Effects: Seek immediate medical attention by calling 911 or visiting the nearest emergency room. c) Medical Support Line: For urgent but non-emergency concerns, call the Silver House Medical Support Line: [Insert Number], available [insert hours]. d) Silver House is committed to patient safety and encourages you to report any side effects or concerns promptly.

22. Right to Discontinue or Terminate Treatment

Silver House reserves the right to pause or discontinue your participation in the BAT Pill Protocol if: a) Medical Safety Concerns: Continuing treatment poses a risk to your health, as determined by your provider. b) Non-Compliance: You fail to attend required follow-up appointments, complete lab testing, or adhere to the treatment plan. c) Emerging Medical Evidence: New research indicates that continued participation may not be in your best interest. You may also voluntarily discontinue treatment at any time, but you should consult your provider to ensure a safe transition and discuss any follow-up care.

23. Governing Law

These BAT Pill Protocol Terms are governed by the same laws and dispute resolution procedures outlined in the BATWatch Terms of Service, including the choice of law and jurisdiction clauses.

24. No Waiver

Failure by Silver House to enforce any provision of these Terms shall not be construed as a waiver of any rights under these Terms or applicable law.

25. Severability 

If any provision of these Terms is found to be unenforceable or invalid, the remaining provisions shall remain in full force and effect.

25. Revision and Notice Clause

Silver House may update these BAT Pill Protocol Terms of Service from time to time to reflect changes in research, regulations, or treatment protocols. a) Notice of Changes: You will be notified of material updates via email or through the BATWatch patient portal. b) Acceptance of Changes: Continued participation in the BAT Pill Protocol after updates are communicated constitutes acceptance of the revised terms.

26. Patient Informed Consent

By participating in the BAT Pill Protocol (“BPP”), you confirm the following: a) Off-Label Use Acknowledgment: You understand that the BPP uses Sirolimus (Rapamycin) off-label, which is a common, evidence-based practice recognized by the medical community. 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, and all your questions have been answered to your satisfaction. d) No Guarantees: You acknowledge that Silver House has not promised or guaranteed any specific outcomes. e) Voluntary Participation: You voluntarily consent to participate in the BAT Pill Protocol. This acknowledgment is made with full understanding and is part of your informed consent for participation.