Silver House: Legal

1. What is BATWatch™?

1.1 BATWatch™ is a comprehensive, collaborative care program developed to address the growing gaps in cognitive health management, with a particular focus on the early detection, monitoring, and treatment of Beta-Amyloid and Tau (BAT) levels, the key biomarkers for Alzheimer’s risk.

Recognizing the challenges faced by primary care providers (PCPs) in managing cognitive health alongside numerous other conditions, BATWatch™ was created to offer an advanced framework that provides continuous oversight, diagnostic support, and targeted treatment options that can be seamlessly integrated into existing PCP workflows.

1.2 The Challenge: Despite the significant advancements in understanding BAT Levels™ as one of the highest risk factors for Alzheimer’s disease, we face ongoing hurdles in both awareness and application. The cognitive health space is evolving, yet it remains fragmented, especially in the realm of primary care.

According to recent studies by the World Health Organization (WHO), nearly 50% of Alzheimer’s cases are misdiagnosed or missed altogether, often because routine annual wellness exams lack the in-depth cognitive evaluations necessary to detect early signs of cognitive decline.

Primary care providers, while vital, are stretched thin managing a wide variety of health concerns—from heart disease to diabetes to mental health. As a result, cognitive health is frequently under-assessed, and patients at the highest risk for Alzheimer’s often go undiagnosed until symptoms are more severe.

Given the rapidly advancing field of cognitive health, it’s becoming increasingly difficult for general practitioners to stay on top of new diagnostic tools and treatment protocols.

1.3 The Solution: BATWatch™ addresses these challenges by offering a collaborative solution that empowers providers with the tools, resources, and expertise to ensure their patients receive the highest standard of care without overwhelming their practices.

2. Collaboration with Providers:

2.1 Cognitive Health Extension: BATWatch™ is designed to seamlessly integrate into the workflows of primary care practices. By providing providers with access to advanced diagnostic tests and innovative treatment protocols, the program ensures that cognitive health is managed effectively while the providers maintain their focus on general care.

Through a referral-based system, providers can easily send patients for BAT Testing™, cognitive assessments, and treatment, while BATWatch™ manages the day-to-day intricacies of cognitive care, such as test coordination, ongoing monitoring, and treatment adjustments.

2.2 Proactive Monitoring: The core of BATWatch™ is proactive, continuous monitoring of a patient’s BAT Levels™ using the proprietary BAT Test Protocol™. The protocol includes a series of diagnostic tools that measure Beta-Amyloid and Tau levels, the primary biomarkers for Alzheimer’s disease.

Based on these results, patients receive personalized, proactive care, which can include early interventions aimed at delaying or preventing the progression of Alzheimer’s disease. This system not only helps detect risks early but also ensures patients receive consistent, tailored treatment over time.

2.3 Expert Management: Providers often face difficulty prescribing off-label treatments or keeping up with the evolving field of cognitive health. BATWatch™ takes on the responsibility of managing complex treatments such as those involving BAT Pill Protocol™, which includes innovative treatments designed to address the patient’s unique BAT Levels™.

The protocol involves continuous adjustment of the treatment plan based on the patient’s biomarker response and overall cognitive health. BATWatch™ also handles the prescription and management of side effects, ensuring that all treatments are closely monitored and optimized to meet individual needs.

3. Additional Provider Benefits:

3.1 BATWatch™ offers a range of benefits for healthcare providers seeking to improve patient outcomes in cognitive health, while easing the burden on their practice.

3.2 Ease of Integration: BATWatch™ requires no major changes to the provider’s existing infrastructure. Providers simply refer patients to the program, where cognitive health experts take over the management and implementation of specialized testing and treatment. This allows the provider to stay focused on the overall health of the patient, without needing to dedicate extensive time and resources to managing the complexities of cognitive care.

3.3 Specialized Expertise: Cognitive health is an ever-evolving field, with new diagnostics and treatments regularly emerging. Through BATWatch™, providers gain access to the latest advancements in Alzheimer’s prevention and treatment, without needing to personally keep up with the scientific and medical developments. BATWatch™ serves as a collaborative partner, providing ongoing education and support to ensure patients receive the best possible care based on the latest clinical evidence.

3.4 Improved Patient Care: With BATWatch™, patients benefit from a dedicated, structured framework for cognitive health. They receive consistent assessments and timely interventions that can significantly improve their chances of preventing the progression of Alzheimer’s disease. Providers can be confident their patients are receiving the most up-to-date care without placing additional pressure on their already busy schedules.

3.5 Ongoing Communication and Reporting: Providers who join BATWatch™ will be automatically setup with a streamlined ecosystem to receive continuous updates on their patients’ cognitive health status. Our system ensures that every test result, treatment adjustment, and assessment is reported back to the provider so they remain informed of their patient’s progress and care plan. This ongoing communication reinforces the partnership between providers and BATWatch™, ensuring that every patient receives comprehensive care.

4. Components of BATWatch™

4.1 BATWatch™ consists of several key components, each designed to work together within a comprehensive protocol for Alzheimer’s prevention and management. These components are proprietary to Silver House, ensuring an integrated approach to cognitive health monitoring, diagnosis, and treatment.

4.2 Evidence-Based Accuracy and Patient-Centric Focus: While multiple BAT Tests™ exist, we prioritize those with the most robust, evidence-backed accuracy in detecting Alzheimer’s-related biomarkers. BATWatch™ remains lab, test, and treatment agnostic, focusing solely on what delivers the best patient outcomes. Our protocol adapts based on the latest scientific advancements to ensure patients receive the most reliable and clinically supported care. This ensures that our BAT Test Protocol™ provides the most reliable and clinically supported testing methods, as diagnostics dictates treatment and accuracy matters. We continuously evaluate available options and adapt our protocol to incorporate the latest advancements and research-backed diagnostic tools.

5. BAT Test Protocol™

BAT Test Protocol™: The BAT Test Protocol™ is a comprehensive, proprietary framework designed to assess Alzheimer’s risk through the measurement of Beta-Amyloid and Tau levels, collectively referred to as BAT Levels™. These biomarkers are critical in determining a patient’s potential for developing Alzheimer’s disease, often years before symptoms appear.

The BAT Test Protocol™ is designed to detect Alzheimer’s risk at its earliest stages, long before cognitive symptoms arise. By continuously monitoring BAT Levels™, healthcare providers can intervene with treatment and preventive measures early, potentially delaying the onset of Alzheimer’s disease. Ongoing BAT Testing™ ensures that any changes in biomarker levels are detected in real-time, allowing for timely adjustments to the patient’s care plan.

6. BAT Tests™:

6.1 BAT Tests™ are a variety of advanced diagnostic tools that measure Beta-Amyloid and Tau levels to deliver highly accurate insights into Alzheimer’s risk. For the first time, we have the potential to detect Alzheimer’s risk up to 10-20 years before symptoms appear—potentially transforming Alzheimer’s from a late-stage crisis into a manageable, early-stage condition. Our protocol adapts as new, reliable technologies emerge, ensuring the highest accuracy possible is always in our patients’ prevention arsenal.

6.2 BAT Testing™: The process of selecting and conducting biomarker tests that provide accurate and reliable insights into BAT Levels™. BAT Testing™ also involves selecting and conducting the most appropriate biomarker tests for each patient, based on their unique clinical profile and risk factors

7. BAT Levels™: Recent breakthroughs have identified BAT Levels™ as the primary marker for Alzheimer’s risk, overshadowing other known factors like genetics, environmental influences, and age-related brain changes.

BAT stands for Beta-Amyloid and Tau levels, which are key biomarkers for Alzheimer’s risk. Most people know how cholesterol can clog up arteries and block blood flow. This discovery not only redefines our understanding but also opens new pathways for prevention and management of the disease.

Beta-Amyloid act in a similar way, by building up like plaque around your brain cells, which disrupts communication and leads to memory problems, confusion, and thinking issues. That’s why people may also hear them referred to as Beta-Amyloid Plaques. And most people know that diabetes is a condition where the body struggles to regulate glucose levels, impacting how nutrients are delivered and used by cells.

Tau has a similar regulation issue, but in the brain. As tau proteins begin clumping together INSIDE the brain cells, they disrupt the transport system of nutrients and information essential for cell survival, which eventually leading to cell death. These clumps look like tangled threads, which is why people may hear them referred to as tau tangles.

So, the higher BAT Levels are, the higher the risk level for developing Alzheimer’s. Having high BAT Levels is like having high cholesterol or blood sugar. The higher the cholesterol levels are, the higher risk of developing heart disease, and same with blood sugar leading to diabetes. So, high BAT Levels, left untreated, can lead to the development of Alzheimer’s.

By understanding and managing BAT Levels—similar to how we manage cholesterol for heart disease—we can potentially prevent Alzheimer’s from ever fully developing, turning it into a manageable condition.

8. BAT Level Index™

8.1 BAT Level Index™: The BAT Level Index (BLI) is a proprietary scoring system designed to predict the likelihood of Alzheimer’s disease by integrating multiple biomarkers and patient-specific data. The BLI incorporates ratios of Beta-Amyloid (Aβ) proteins, Apolipoprotein E (ApoE) genotypes, and the patient’s age to calculate a personalized score that reflects the risk of amyloid plaque accumulation in the brain.

This creates a score ranging from 0 to 100, provides a comprehensive assessment of the patient’s Alzheimer’s risk, offering insight into whether they fall within a low, intermediate, or high-risk category for amyloid plaque buildup. The BLI does not rely on any single test but uses an adaptive algorithm that can incorporate the results from any validated, high-accuracy biomarker testing available on the market.

The BLI’s calculations are based on the latest research in protein biomarkers, using both well-established and emerging diagnostic techniques to ensure accuracy and reliability. Our methodology includes integrating advanced analytics from tests like mass spectrometry and liquid chromatography, but remains adaptable to the most recent scientific discoveries, without being reliant on any specific lab or testing method.

8.2 BAT Risk Score™: The BAT Risk Score™ is a critical risk stratification tool derived from the BLI. It evaluates a patient’s risk of developing Alzheimer’s based on their BAT Levels™, genetic factors, and other clinical data. This score guides healthcare providers in tailoring preventive and treatment strategies based on the calculated risk.

9. BAT Pill Protocol™: BAT Pills™: A BAT Pill™ refers to any oral treatment protocol targeting Beta-Amyloid and Tau (BAT) proteins, critical biomarkers for Alzheimer’s risk. These treatments undergo rigorous clinical evaluation to assess their ability to reduce BAT Levels™ and manage cognitive decline.

Our current focus are drugs undergoing rigorous evaluations for their ability to utilize the body’s natural cleanup system, known as autophagy, to reduce harmful cell waste and misfolded proteins, which include BAT levels. However, a BAT Pill™ could encompass other oral treatments that meet similar objectives. As new research emerges, other oral treatments meeting the same objectives may be incorporated into the BAT Pill Protocol™, ensuring patient safety and optimal outcomes.

10. BATophagy™: BATophagy™ treatment method focused on an enhanced autophagy-related interventions to target and break down Beta-Amyloid and Tau proteins. BATophagy™ stimulates the body’s natural cellular cleanup process, removing these harmful proteins and reducing the risk of cognitive decline.

11. Current Cognitive Screening Age Recommendation: Current recommendations by the U.S. Preventive Services Task Force (USPSTF) suggest starting cognitive screening at age 65, based on older data that does not fully consider the potential of advanced biomarker tests. These recommendations overlook significant advancements in early detection technology and the importance of screening for betaamyloid and tau (BAT) levels earlier.

12. Rationale for Biomarker Screening Age of 45: The graph below underscores the critical importance of early biomarker screening for Alzheimer’s disease, starting in the mid-40s. Waiting until clinical symptoms appear, or until age 65 for biomarker testing can significantly reduce the effectiveness of potential interventions, as beta-amyloid and tau pathologies have already progressed substantially. Early detection through biomarker screening can lead to timely interventions that might delay or prevent the onset of clinical symptoms. Alzheimer’s Association. (2017) Anderson, J., et al. (2022). Galasko, D. R., et al. (2022) Jack, C. R., et al. (2013) Meyer, M. R., et al. (2024) Monane, M., et al. (2023) Schindler, S. E., et al. (2019) Sperling, R. A., et al. (2011) Wang, G., et al. (2018)

13. Why do we use ‘BAT’ Descriptors?

We have adopted terms to simplify complex medical concepts for the public.
Most people perceive Alzheimer’s and dementia as irreversible and devastating diagnoses, often too daunting to even consider addressing. This fear, compounded by misinformation or a lack of education about available options, can prevent individuals from seeking necessary care.

By utilizing a friendly, less clinical, and approachable naming structure, we aim to make cognitive health management more accessible, less intimidating, and engaging by reducing fear and anxiety around Alzheimer’s and dementia, to help people grasp the significance of ongoing monitoring and prevention efforts.

By offering these easily understandable terms, we’re breaking down barriers to accessing care, increasing awareness, and making cognitive health management more accessible.

14. Liability and Research Disclosures

14.1 By enrolling in the BATWatch™ Program, you acknowledge that BAT Tests™ and BAT Pill™ treatments represent innovative approaches to Alzheimer’s prevention and cognitive health management, grounded in evolving clinical research. As a participant, you understand that:

14.2 Experimental Nature of Treatments: Some components of the program, including the BAT Pill™, are prescribed based on decades of previous and ongoing research into Alzheimer’s prevention. These treatments may not yet have specific FDA approval for Alzheimer’s prevention and are used in alignment with current scientific understanding. While these treatments show promise, they are subject to change as new research and evidence emerge.

14.3 Accuracy of BAT Testing: BAT Tests™ are based on the most accurate non-invasive testing protocols currently available, providing robust predictions for amyloid plaque buildup. However, no diagnostic test is 100% accurate. False positives or negatives may occur, and your BAT Level™ results should always be reviewed alongside a comprehensive evaluation by your healthcare provider to determine the best course of action.

14.4 BAT Pill™ Treatment: The BAT Pill™ Protocol involves the use of treatments that target Beta-Amyloid and Tau levels, leveraging decades of research and clinical trials that provide substantial evidence supporting our studies and the off-label use of BAT Pills™. While these treatments are designed to manage BAT Levels™, they may still be considered off-label treatment for Alzheimer’s prevention. Results from our ongoing clinical trials and ongoing clinical studies will provide more information about the efficacy and safety of this treatment. The information provided is for educational purposes and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Until FDA approval is obtained, any claims regarding the effectiveness of the BAT Pill Protocol™ is based on early research and has not been conclusively established.

14.5 No Formulation Changes: Referring to treatments as a 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 BAT Pill Protocol™ have well-documented safety profiles, although primarily prescribed under strict medical supervision due to their range of possible 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.

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. Release of Liability: Should You become a patient of Silver House, and wish to participate in the BATWatch™ Program, You, and on behalf of your spouse, children, parents, guardians, heirs, next of kin, and any legal or personal representatives, executors, administrators, successors and assigns, or anyone else who might claim or sue on your behalf, (“Releasing Parties”) agree that by participating in the BATWatch™ Program, hereby release Silver House, its directors, officers, employees, agents, contractors, insurers, spectators, co-participants, equipment suppliers, and volunteers; all Community Members, participating healthcare providers, Venue and their directors, officers, employees, agents, contractors, insurers, equipment suppliers, and volunteers; all by Silver House sponsors, organizers, promoters, directors, officials, and property owners; governmental bodies and/or municipal agencies whose property and/or personnel are used; and any or all parent, predecessor, subsidiary or affiliate companies, licensees, officers, directors, partners, board members, supervisors, insurers, agents, equipment suppliers, and representatives of any of the foregoing, (“Released Parties”), from any claims, demands, liabilities, rights, and causes of action of any kind, arising from or related to your participation in the BATWatch™ Program, acknowledging the distinct nature of each and the informed consent You have provided for participation. This release includes, but is not limited to: Individual Variability, Diagnosis Specifics, Treatment History, Adherence to Therapy, Complex Needs, Personal Factors, Aggravation of Pre-existing Conditions, Unpredictable Incidents, Emotional Stress, Frustration and Emotional Distress, Reaction to Medication, Adjustment Period, Interpersonal Dynamics, Unintended Consequences.

17. Assumption of Risk: By participating in the BATWatch™ Program, you acknowledge and accept that you are voluntarily assuming all risks associated with BAT Tests™ and BAT Pill™ treatments. These risks include, but are not limited to, adverse side effects, treatment failure, unpredictable medical complications, and the evolving nature of research-based protocols. You understand that outcomes vary based on individual factors, including personal medical history, responsiveness to treatment, and adherence to therapy. Participation in the program is based on your informed consent and awareness of these risks.

18. Indemnification: By participating in the BATWatch™ Program, you agree to indemnify, defend, and hold harmless Silver House, its affiliates, employees, contractors, and any related parties from any claims, actions, or liabilities arising out of your participation in the program. This includes, but is not limited to, medical complications, adverse reactions, or any legal claims resulting from your use of BAT Tests™ or BAT Pill™ treatments. You assume full responsibility for any costs, losses, or damages incurred in connection with your participation.

19. No Guarantees: BATWatch™, Silver House Healthcare, and BATWatch LLC make no guarantees regarding the specific outcomes of BAT Tests™ or BAT Pill™ treatments. While our goal is to prevent or delay cognitive decline by utilizing advanced diagnostic tools and targeted treatments, individual results may vary significantly. Factors such as a patient’s genetic makeup, lifestyle, existing health conditions, and responsiveness to treatment can all influence the effectiveness of these interventions. Given these variables, it is important to understand that results cannot be guaranteed.

20. Consent to Testing and Treatment: By participating in the program, you consent to undergo diagnostic testing and treatment as recommended by your healthcare provider. You acknowledge that these tests and treatments are part of an ongoing research effort to improve cognitive health outcomes and may involve emerging or off-label practices. Participation is voluntary, and you may opt out at any time.

21. Patient Responsibility: You agree to follow the prescribed treatments and recommendations provided by your healthcare team. Failure to comply with treatment protocols may impact the effectiveness of the program and your cognitive health outcomes.

22. Let’s Do This!

As a Collaborative Care Community, we are committed to revolutionizing cognitive health through proactive Alzheimer’s prevention. BATWatch™ equips you with innovative tools for early detection, ongoing monitoring, and personalized treatments, helping you stay ahead of cognitive decline.

By joining BATWatch™, you’re not just enrolling in a program—you’re becoming part of a community dedicated to empowering your cognitive health. We work alongside you and your healthcare team to support every step of your journey, ensuring peace of mind and the best possible outcomes.

If you have any questions, our team is here to help!