Effects of rapamycin on aging and heart function in the elderly
Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly: Immune, Cognitive, and Functional Consequences ((Substudy E - RAPA cMRI With LGE)
This study is testing if the drug rapamycin can help improve heart health and reduce inflammation in older adults aged 70 to 95.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 70 Years to 95 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT04742777 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of rapamycin, a drug known for its potential to extend lifespan and improve health in older adults, specifically targeting individuals aged 70 to 95. The study aims to evaluate whether rapamycin can enhance cardiac function and reduce age-related inflammation and pathologies in this population. Participants will undergo assessments to determine the drug's effects on heart health and overall well-being. The trial is a sub-study of a larger investigation into aging and immune response.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 70-95 with stable chronic conditions.
Not a fit: Patients with diabetes, liver disease, or those on certain medications affecting drug metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and overall quality of life for elderly patients.
How similar studies have performed: Previous studies have shown promising results with rapamycin in animal models, but this specific approach in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * men and women 70-95 years of age. * Subjects will be in good general health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Selected subjects will be in good health (Per the World Health Organization good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity. * For our purposes all diseases or infirmities will be clinically stable whether managed by medications or not. * All ethnicities will be included. * For cardiac and brain imaging by MRI, a pre-MRI screening questionnaire will be used to assess MRI safety and neurological health. Exclusion Criteria: * Diabetes, (with A1c ≥6.5 or if treated with medication affecting glucose homeostasis History of skin ulcers or poor wound healing, * Smoking, * Liver disease, * Anti-coagulation, * Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc) due to its role in RAPA metabolism, * Treatment (\>30days of therapy or long term) with a systemic immunosuppressant (prednisone, etc.) within the last year, * History of recent (within 6 months) Myocardial Infarction or active Coronary Disease, * Patients with history of recent (within 6 months) intestinal disorders, * Exclusion criteria for MRI scan: known claustrophobia, metal implants in soft tissue of the body including pacemakers, aneurysm clips, ferrous metal fragments not anchored to bone (bullets, BBs, shrapnel, metal shavings), implanted medication pumps, and oral-facial metal appliances that are permanently secured but may result in low image quality. Participants may also be excluded for history of severe head trauma, brain injury, brain surgery, inflammation of the brain, or history of seizures. * Positive COVID19 test.
Where this trial is running
San Antonio, Texas and 1 other locations
- Audie L. Murphy Memorial Veterans Hospital — San Antonio, Texas, United States (Recruiting)
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dean L Kellogg, Jr., MD PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Dean L Kellogg, Jr., MD PhD
- Email: kelloggd@uthscsa.edu
- Phone: 210-617-5197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.