Purpose

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

IRB Number
STUDY00000471
NCT Number
-
Sponsor
-



Study Contact

Ellen Kraig
210-567-3818
kraig@uthscsa.edu

Principal Investigator
Ellen Kraig

Dean Kellogg
210-617-5311
kelloggd@uthscsa.edu

Tiffany Cortes
210-450-8998
cortest@uthscsa.edu



Eligibility

Eligible Ages
65-90
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

Arm Groups