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Lay Description

Studies in mice have identified drugs that slow the aging process. This study is focused on one such family of drugs, called mTOR inhibitors. We will test two of these drugs in healthy older adults to find a protocol that can be used safely.

Category

  • Healthy Subjects Needed
  • Aging and Geriatric
IRB Number
STUDY00000471
NCT Number
ct.gov registration not required
Open to Enrollment
Not set

Eligibility

Eligible Ages
-
Eligible Genders
all
Accepts Healthy Volunteers
Yes

Inclusion Criteria

1)      In good health with all medical problems stable

2)      Community-dwelling

3)      Agreement to adhere to Lifestyle Considerations throughout study duration

4)     Ability of participant to understand and the willingness to sign a written informed consent document

5)     Willingness to take study medication as directed

Exclusion Criteria

  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 or e-cigarette 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 Montreal Cognitive Assessment (MOCA) score <21 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 seizures
  19. History of Long-Covid (PASC)
  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 (Substudy 3, Aim 2 only)
  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/medication contained these, or related, substances
  28. Currently using hormone replacement or modulating therapies

Study Design

Study Contact

Regulatory Point of Contact
Dean Kellogg
210-617-5311
kelloggd@uthscsa.edu

Regulatory Point of Contact
Tiffany Cortes
210-450-8998
cortest@uthscsa.edu

Overall Recruitment Point of Contact
Ellen Kraig
210-567-3818
kraig@uthscsa.edu

Principal Investigator
Ellen Kraig