RESTOR

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.

• Male or female
• Ages 65-90
• In good health with all medical problems stable
• Community-dwelling
• Agreement to adhere to Lifestyle Considerations throughout study duration
• Ability of participant to understand and the willingness to sign a written informed consent document
• Willingness to take study medication as directed

• Resident of nursing home or long-term care facility
• Subjects with diabetes or currently taking glucose lowering medications
• 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
• Active cancer or history of cancer treatment within the last 5 years
• 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)
• History of a coagulopathy or any medical condition requiring anticoagulation (except low dose ASA)
• Renal insufficiency with an estimated glomerular filtration rate of <30ml/min
• Uncontrolled hypercholesterolemia >350mg/dl or uncontrolled hypertriglyceridemia >500mg/dl
• 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
• History of skin ulcers or poor wound healing
• Active tobacco or e-cigarette use (within 6 months)
• 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
• Liver disease
• Systemic treatment with an immunosuppressant (prednisone, etc.) within the year prior to enrollment
• Treatment with drugs known to affect cytochrome P450 (CYP3A4), i.e., diltiazem, erythromycin
• Patients with history of recent (within 6 months) myocardial infarction or active coronary disease
• Patients with history of recent (within 6 months) intestinal disorders
• History of severe head trauma, brain injury, brain surgery, inflammation of the brain, or history of seizures
• History of Long-Covid (PASC)
• Acute Covid19 or Covid19 infection within the last 6 months
• Unwilling to forgo grapefruit juice consumption
• 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.)
• Allergic to RAPA or EVERO
• Allergic to lidocaine (Substudy 3, Aim 2 only)
• Recreational drug use
• Donated blood over a two-month period prior to study initiation
• Currently using cannabidiol (CBD) or tetrahydrocannabinol (THC) or any preparation/medication contained these, or related, substances
• Currently using hormone replacement or modulating therapies

UT Health San Antonio
Sam and Ann Barshop Institute for Longevity and Aging Studies
4939 Charles Katz Dr.
San Antonio, TX 78229

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