mTOR medicines for healthier aging in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial will give older adults short courses of sirolimus or everolimus and collect serial blood samples to define pharmacokinetics and pharmacodynamics in this age group. Researchers will measure a senescence-associated secretory phenotype (SASP) index at baseline and 3 months to see whether those biomarkers shift with treatment. The study also collects exploratory laboratory measures (ESR, CRP, S6K activity, mitochondrial function, metabolomics) and functional tests (walking speed, chair stand, standing balance, grip strength). Results are intended to define safe dosing and biological signals to guide larger trials of mTOR inhibitors for aging-related outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Irina Timofte, MD, MS — University of Texas Southwestern Medical Center
• Study coordinator: Irina Timofte, MD, MS
• Email: Irina.Timofte@utsouthwestern.edu
• Phone: 2163347534

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.