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RecruitingPhase 1, Phase 2NCT06727305

MTOR Inhibitors in Older Adults

Trial Parameters

ConditionAging
SponsorUniversity of Texas Southwestern Medical Center
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment60
SexALL
Min Age65 Years
Max Age80 Years
Start Date2026-02
Completion2027-09-01
Interventions
Sirolimus 0.5 Mg Oral TabletSirolimus 1Mg Oral TabletSirolimus 2 MG Oral Tablet

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Brief Summary

Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications

Eligibility Criteria

Inclusion Criteria: 1. Community-dwelling adults 2. Patients should be 65 Years and older 3. Patients is able to understand and follow trial procedures Exclusion Criteria: 1. Creatinine clearance \<30 mL/min; 2. History of chronic liver disease; 3. Uncontrolled Hypertension (i.e., systolic blood pressure \>160 mm Hg); 4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit; 5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation; 6. Planned major surgical procedures; 7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months); 8. Taking medication that increase or decrease sirolimus blood concentrations; 9. Other investigational therapy received within 1 month prior to screening visit; 10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.

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