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Recruiting
NCT06727305
MTOR Inhibitors in Older Adults
Conditions: Aging
Sex: All
Ages: 65 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center Dallas Texas
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 \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.
Source: ClinicalTrials.gov (NCT06727305). StuddyBuddy aggregates publicly available trial information.