NCT06658093 RESTOR: PK/PD mTORi Inhibition in Older Adults
| NCT ID | NCT06658093 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 194 participants in total. It began in 2026-03-04 with a primary completion date of 2028-07.
⚠ 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
As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.
Eligibility Criteria
Inclusion Criteria: Older Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2): 1. Age ≥65 to 90 years 2. Men and women 3. In good health with all medical problems stable. 4. Community-dwelling 5. Agreement to adhere to Lifestyle Considerations throughout study duration. 6. Ability of participant to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Older Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2): 1. Resident of nursing home or long-term care facility 2. Subjects with diabetes or currently taking glucose lowering medications 3. History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation); Moderate to severe valvular heart disease 4. Active cancer or history of cancer treatment within the last 5 years 5. Chronic inflammatory condition, autoimmune disease, or infectious processes (e.g., active tuberculosis, HIV, rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C) 6. History of a coagulopathy or any medical condition requiring anticoagulation (except low dose ASA) 7. Renal insufficiency with an estimated glomerular filtration rate of \<30ml/min 8. Uncontrolled hypercholesterolemia \>350mg/dl or uncontrolled hypertriglyceridemia \>500mg/dl 9. Anemia or abnormal blood cell counts: hemoglobin level \<9.0g.dl; white blood count \<3500/mm3; neutrophil count \<2000/ mm3; platelet count \<125,000/mm3 10. History of skin ulcers or poor wound healing 11. Active tobacco use (within 6 months) 12. Diagnosis of any disabling neurologic disease such as Parkinson's Disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (muscle weakness or gait disorder), severe neuropathy, diagnosis of dementia or Clox1 score less than 10 at the time of screening visit, cognitive impairment due to any reason such that the patient is unable to provide informed consent 13. Liver disease 14. Systemic treatment with an immunosuppressant (prednisone, etc.) within the year prior to enrollment 15. Treatment with drugs known to affect cytochrome P450 (CYP3A4), i.e., diltiazem, erythromycin. 16. Patients with history of recent (within 6 months) myocardial infarction or active coronary disease 17. Patients with history of recent (within 6 months) intestinal disorders 18. History of severe head trauma, brain injury, brain surgery, inflammation of the brain, or history of seizure disorder 19. History of Long-Covid (PASC) within one year 20. Acute Covid19 or Covid19 infection within the last 6 months 21. Unwilling to forgo grapefruit juice consumption. 22. Participation in mTORi study within the prior year. (Note: participants in AIM 1 will be excluded from participating in AIM 2 of the proposed trial.) 23. Allergic to RAPA or EVERO 24. Allergic to lidocaine 25. Recreational drug use 26. Donated blood over a two-month period prior to study initiation. 27. Currently using cannabidiol (CBD) or tetrahydrocannabinol (THC) or any preparation contained these, or related, substances. 28. Currently using hormone replacement or modulating therapies.
Contact & Investigator
Ellen Kraig, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT06658093 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 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 NCT06658093 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 NCT06658093 currently recruiting?
Yes, NCT06658093 is actively recruiting participants. Contact the research team at kelloggd@uthscsa.edu for enrollment information.
Where is the NCT06658093 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06658093 clinical trial?
NCT06658093 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Ellen Kraig, PhD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 194 participants.