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MTOR Inhibitors in Older Adults

Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .

Who can join

Ages 65 to 80 · All sexes · Healthy volunteers welcome

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.

About the study

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

What is being tested

• Sirolimus 0.5 Mg Oral Tablet (drug)
• Sirolimus 1Mg Oral Tablet (drug)
• Sirolimus 2 MG Oral Tablet (drug)
• Everolimus 0.5 MG Oral Tablet (drug)
• Everolimus 1 MG Oral Tablet (drug)
• Everolimus 2 MG Oral Tablet (drug)

Sponsor: University of Texas Southwestern Medical Center · Participants: 60 · Started: May 11, 2026

Contact the study team

• Irina Timofte, MD, MS · Phone: 2163347534

Official record on ClinicalTrials.gov — NCT06727305

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.