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Mar. 30th, 2025 10:42 pm![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
shiningfractalScientific Trial Design for a Multi-Drug Anti-Aging Therapy
This study aims to determine the optimal dosage, efficacy, and side effects of a drug cocktail combining telomerase activation, senolytics, mTOR inhibitors, and epigenetic reprogramming in humans. Given the complexity and potential risks, the study will progress through multiple phases, starting with safety and escalating toward long-term efficacy.
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1. Study Overview
Title: Multi-Pathway Anti-Aging Therapy: A Dose-Response and Safety Study in Human Volunteers
Design: Double-blind, placebo-controlled, randomized clinical trial
Participants: Healthy volunteers aged 40–60 years (n = 5,000)
Duration: 10 years (with interim 1-year, 5-year analyses)
Primary Outcomes: Longevity biomarkers, adverse effects, cellular aging reversal
Secondary Outcomes: Cognitive function, immune response, cancer incidence
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2. Drug Cocktail Components and Dosage Ranges
1. Telomerase Activator – (e.g., TA-65 or AAV9-hTERT gene therapy)
Doses: Low (10% of known max safe dose), Medium (50%), High (100%)
Risk: Cancer cell proliferation
2. Senolytics – (e.g., Dasatinib + Quercetin, Navitoclax, Fisetin)
Doses: Once per 3 months (intermittent clearance approach)
Risk: Excessive tissue loss, immune suppression
3. mTOR Inhibitor – (e.g., Rapamycin or Everolimus)
Doses: 0.5 mg, 1 mg, 5 mg weekly
Risk: Impaired immune function, metabolic slowdown
4. Epigenetic Reprogramming – (Partial Yamanaka Factors - OSK, omitting c-Myc)
Delivery: Viral (AAV) or mRNA-based dosing every 6 months
Risk: Uncontrolled cell dedifferentiation, tumorigenesis
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3. Study Phases
Phase 1 – Safety & Initial Dosing (Year 1–2, n = 500 volunteers)
Goal: Identify maximum tolerable doses, immediate toxicity, and short-term adverse effects
Monitoring:
Regular blood tests (immune markers, liver/kidney function)
Imaging (MRI, PET scans for tumor formation)
Telomere length measurement
Senescent cell burden analysis
Exclusion Criteria: Any early signs of cancer, severe immune suppression
Phase 2 – Efficacy & Optimal Dose Finding (Year 3–6, n = 2,000 volunteers)
Groups:
Control (Placebo)
Low Dose (10% max dose of all)
Medium Dose (50% of safe dose)
High Dose (100% of safe dose)
Alternating Dose (Senolytics and Epigenetic Reprogramming staggered)
Measurements:
Cellular Aging: Telomere length, epigenetic clock (Horvath clock)
Cognitive Function: Memory, reaction time tests
Systemic Health: Inflammatory markers, cardiovascular health
Phase 3 – Long-Term Effects (Year 7–10, n = 5,000 volunteers)
Goal: Determine lifespan extension, long-term risks (e.g., cancer, immune dysfunction)
Methods:
Quarterly checkups: Blood panels, cognitive tests, imaging
Yearly deep tissue biopsies: Check for undetected tumors
Survival rate comparison: Disease-free lifespan vs. control
---
4. Data Analysis & Ethical Considerations
Stopping Criteria: If cancer rates significantly increase in any group, that arm is terminated.
Adaptive Dosing: Adjust doses based on interim results to balance efficacy and safety.
Participant Rights: Fully informed consent, ability to opt out at any time.
---
Expected Outcomes & Challenges
✅ Success: If an optimal dose is found that extends lifespan without increasing cancer risk or severe side effects, further refinement for mainstream therapy can begin.
⚠️ Challenges: Managing risks of excessive telomerase activation, immune suppression, and unintended cellular dedifferentiation.
Would you want to refine this to include specific genetic engineering aspects for better control?
***
This study aims to determine the optimal dosage, efficacy, and side effects of a drug cocktail combining telomerase activation, senolytics, mTOR inhibitors, and epigenetic reprogramming in humans. Given the complexity and potential risks, the study will progress through multiple phases, starting with safety and escalating toward long-term efficacy.
---
1. Study Overview
Title: Multi-Pathway Anti-Aging Therapy: A Dose-Response and Safety Study in Human Volunteers
Design: Double-blind, placebo-controlled, randomized clinical trial
Participants: Healthy volunteers aged 40–60 years (n = 5,000)
Duration: 10 years (with interim 1-year, 5-year analyses)
Primary Outcomes: Longevity biomarkers, adverse effects, cellular aging reversal
Secondary Outcomes: Cognitive function, immune response, cancer incidence
---
2. Drug Cocktail Components and Dosage Ranges
1. Telomerase Activator – (e.g., TA-65 or AAV9-hTERT gene therapy)
Doses: Low (10% of known max safe dose), Medium (50%), High (100%)
Risk: Cancer cell proliferation
2. Senolytics – (e.g., Dasatinib + Quercetin, Navitoclax, Fisetin)
Doses: Once per 3 months (intermittent clearance approach)
Risk: Excessive tissue loss, immune suppression
3. mTOR Inhibitor – (e.g., Rapamycin or Everolimus)
Doses: 0.5 mg, 1 mg, 5 mg weekly
Risk: Impaired immune function, metabolic slowdown
4. Epigenetic Reprogramming – (Partial Yamanaka Factors - OSK, omitting c-Myc)
Delivery: Viral (AAV) or mRNA-based dosing every 6 months
Risk: Uncontrolled cell dedifferentiation, tumorigenesis
---
3. Study Phases
Phase 1 – Safety & Initial Dosing (Year 1–2, n = 500 volunteers)
Goal: Identify maximum tolerable doses, immediate toxicity, and short-term adverse effects
Monitoring:
Regular blood tests (immune markers, liver/kidney function)
Imaging (MRI, PET scans for tumor formation)
Telomere length measurement
Senescent cell burden analysis
Exclusion Criteria: Any early signs of cancer, severe immune suppression
Phase 2 – Efficacy & Optimal Dose Finding (Year 3–6, n = 2,000 volunteers)
Groups:
Control (Placebo)
Low Dose (10% max dose of all)
Medium Dose (50% of safe dose)
High Dose (100% of safe dose)
Alternating Dose (Senolytics and Epigenetic Reprogramming staggered)
Measurements:
Cellular Aging: Telomere length, epigenetic clock (Horvath clock)
Cognitive Function: Memory, reaction time tests
Systemic Health: Inflammatory markers, cardiovascular health
Phase 3 – Long-Term Effects (Year 7–10, n = 5,000 volunteers)
Goal: Determine lifespan extension, long-term risks (e.g., cancer, immune dysfunction)
Methods:
Quarterly checkups: Blood panels, cognitive tests, imaging
Yearly deep tissue biopsies: Check for undetected tumors
Survival rate comparison: Disease-free lifespan vs. control
---
4. Data Analysis & Ethical Considerations
Stopping Criteria: If cancer rates significantly increase in any group, that arm is terminated.
Adaptive Dosing: Adjust doses based on interim results to balance efficacy and safety.
Participant Rights: Fully informed consent, ability to opt out at any time.
---
Expected Outcomes & Challenges
✅ Success: If an optimal dose is found that extends lifespan without increasing cancer risk or severe side effects, further refinement for mainstream therapy can begin.
⚠️ Challenges: Managing risks of excessive telomerase activation, immune suppression, and unintended cellular dedifferentiation.
Would you want to refine this to include specific genetic engineering aspects for better control?
***
