RECRUITING

RESTOR: PK/PD mTORi Inhibition in Older Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects

Quick Facts

Study Start:2025-08-13

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06658093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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.

Inclusion Criteria

Exclusion Criteria

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.

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.

Contacts and Locations

Study Contact

Dean L Kellogg, Jr, MD PhD

CONTACT

(210) 617 5197

kelloggd@uthscsa.edu

Ellen Kraig, PhD

CONTACT

(210) 367-3171

kraig@uthscsa.edu

Principal Investigator

Ellen Kraig, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Ellen Kraig, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-13

Study Completion Date2028-07

Study Record Updates

Study Start Date2025-08-13

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

mTOR inhibitors

Additional Relevant MeSH Terms

Aging