Early phase 1Recruiting
RESTOR: PK/PD mTORi Inhibition in Older Adults
RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects
- Sponsor
- The University of Texas Health Science Center at San Antonio (Academic or other)
- Enrolment
- 194 planned
- Conditions
- Aging
- Interventions
- Rapamycin; Everolimus; Placebo
- Ages
- older adults
- Registry
- NCT06658093
From the registry
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.
Primary outcomes
- Pharmacokinetics (PK) of mTOR inhibitor in blood
- PD measure of inhibition of mTOR activity in blood cells - p-rpS6
- Level of Soluble Intercellular Adhesion Molecule-1 (sICAM-1)