NCT06727305 MTOR Inhibitors in Older Adults
| NCT ID | NCT06727305 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-02 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<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.
Contact & Investigator
Irina Timofte, MD, MS
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06727305 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 80 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06727305 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06727305 currently recruiting?
Yes, NCT06727305 is actively recruiting participants. Contact the research team at Irina.Timofte@utsouthwestern.edu for enrollment information.
Where is the NCT06727305 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06727305 clinical trial?
NCT06727305 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Irina Timofte, MD, MS at University of Texas Southwestern Medical Center. The trial plans to enroll 60 participants.