Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria: age 70-95

• participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.

• participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria:

• unstable ischemic heart disease

• clinically significant pulmonary disease

• history of immunodeficiency or receiving immunosuppressive therapy

• history of a coagulopathy or receiving a medical condition requiring anticoagulation

• an estimated glomerular filtration rate of <30ml/min

• uncontrolled hypercholesteremia >350mg/dl;

• uncontrolled hypertriglyceridemia >500mg/dl

• diabetes

• history of skin ulcers or poor wound healing

• smoking

• liver disease

• treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)