About this trial
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
Qualifiers
Community-dwelling adults
Patients should be 65 Years and older
Patients is able to understand and follow trial procedures
Disqualifiers
Creatinine clearance <30 mL/min;
History of chronic liver disease;
Uncontrolled Hypertension (i.e., systolic blood pressure >160 mm Hg);
Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
Trial design
Treatments tested in this trial
- Sirolimus 0.5 Mg Oral Tablet
- Sirolimus 1Mg Oral Tablet
- Sirolimus 2 MG Oral Tablet
- Everolimus 0.5 MG Oral Tablet
- Everolimus 1 MG Oral Tablet
- Everolimus 2 MG Oral Tablet
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
University of Maryland, Baltimore
Collaborator
National Institute on Aging (NIA)
Collaborator