drugset / Trial / NCT06727305
MTOR Inhibitors in Older Adults
Phase 1/2
Recruiting
60 enrolled
University of Texas Southwestern Medical Center
National Institute on Aging (NIA) · collabUniversity of Maryland, Baltimore · collab
RandomizedParallel-groupOpen-labelPrevention
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
Timeline
- Start
- 2026-05-11
- Primary completion
- 2027-09-01
- Completion
- 2027-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | 0.5 mg | Oral |
| Comparator | Everolimus | Small molecule | 1 mg | Oral |
| Comparator | Everolimus | Small molecule | 2 mg | Oral |
| Comparator | Sirolimus | Small molecule | 0.5 mg | Oral |
| Comparator | Sirolimus | Small molecule | 1 mg | Oral |
| Comparator | Sirolimus | Small molecule | 2 mg | Oral |
Indications
No indication recorded.