RecruitingEarly Phase 1

RESTOR: PK/PD mTORi Inhibition in Older Adults

United States194 participantsStarted 2026-03-04

Plain-language 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.

Who can participate

Age range

65 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥65 to 90 years
. Men and women
. 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.

Exclusion criteria

. Resident of nursing home or long-term care facility

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics (PK) of mTOR inhibitor in blood

Timeframe: Baseline to study end (approximately 12 months for Aim 2; 12 weeks for Aim 1)

PD measure of inhibition of mTOR activity in blood cells - p-rpS6

Timeframe: Baseline to study end (approximately 12 months for Aim 2; 12 weeks for Aim 1)

Level of Soluble Intercellular Adhesion Molecule-1 (sICAM-1)

Timeframe: Baseline to study end (approximately 12 months)

Trial details

NCT IDNCT06658093

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Dean L Kellogg, Jr, MD PhD

(210) 617 5197 kelloggd@uthscsa.edu

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range

65 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥65 to 90 years
. Men and women
. 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.

Exclusion criteria

. Resident of nursing home or long-term care facility

What they're measuring

Pharmacokinetics (PK) of mTOR inhibitor in blood

Timeframe: Baseline to study end (approximately 12 months for Aim 2; 12 weeks for Aim 1)

PD measure of inhibition of mTOR activity in blood cells - p-rpS6

Timeframe: Baseline to study end (approximately 12 months for Aim 2; 12 weeks for Aim 1)

Level of Soluble Intercellular Adhesion Molecule-1 (sICAM-1)

Timeframe: Baseline to study end (approximately 12 months)