RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects
The University of Texas Health Science Center at San Antonio
Summary
As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.
Description
The study will be done in three parts, each with different human subject groups. Participants may only enroll in one of the sub-studies. Sub-study 1: Determining target mTOR activity values in YOUNG untreated subjects (ages 20-30 years): NOTE: This aim of the study is not a clinical trial, so this population will not be included in participant flow or included as an arm in the study. This study defines "best dose" as the choice of drug, dose, and frequency that will come closest to restoring the "youthful" levels of mTOR activity in an older individual. The investigators first need to measur…
Eligibility
- Age range
- 65–90 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Older Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2): 1. Age ≥65 to 90 years 2. Men and women 3. In good health with all medical problems stable. 4. Community-dwelling 5. Agreement to adhere to Lifestyle Considerations throughout study duration. 6. Ability of participant to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Older Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2): 1. Resident of nursing home or long-term care facility 2. Subjects with diabetes or currently taking glucose lowering medications 3. History o…
Interventions
- DrugRapamycin
mTOR inhibitor
- DrugEverolimus
mTOR inhibitor
- OtherPlacebo
Inert placebo for rapamycin or everolimus
Location
- The University of Texas Health Science Center at San AntonioSan Antonio, Texas