RESTOR: PK/PD mTORi Inhibition in Older Adults

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06658093
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
65 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Rapamycin — DRUG
    mTOR inhibitor
  • Everolimus — DRUG
    mTOR inhibitor
  • Placebo — OTHER
    Inert placebo for rapamycin or everolimus

Study Details

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.

Key Dates

Start date
Mar 4, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Aim 1:Sub-study 2 Daily dosing Cohort Rapamycin
    Aim 1 is an open label, adaptive, dose finding PK/PD trial in older women and men. In sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams of rapamycin (RAPA) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher/lower doses in an adaptive, step-wise trial design.
  • Experimental: Aim 1: Sub-study 2 Daily dosing Cohort Everolimus
    Aim 1 is an open label, adaptive, dose finding PK/PD trial in older women and men. In sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) of everolimus (EVERO) in milligrams based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher/lower doses in an adaptive, step-wise trial design.
  • Experimental: Aim 1:Sub-study 2 Intermittent dosing Cohort Rapamycin
    Aim 1 is an open label, adaptive, dose finding PK/PD trial in older women and men. In sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams and the optimal interval for intermittent delivery of rapamycin (RAPA) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher/lower doses in an adaptive, step-wise trial design.
  • Experimental: Aim 1: Sub-study 2 Intermittent dosing Cohort Everolimus
    Aim 1 is an open label, adaptive, dose finding PK/PD trial in older women and men. In sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams and the optimal interval for intermittent delivery of everolimus (EVERO) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher/lower doses in an adaptive, step-wise trial design.
  • Experimental: Aim 2: Sub-study 3 Optimized DAILY Dose of an mTOR inhibitor
    Based on the findings from Aim 1, the optimal drug (RAPA or EVERO) and dose for DAILY delivery will be tested in a blinded placebo-controlled trial in older human subjects. The drug/dose used in males may differ from the one used in females as the OD will be determined independently for the two sexes. PD parameters 'downstream' from mTOR will be followed.
  • Experimental: Aim 2: Sub-study 3 Optimized INTERMITTENT Dosing of an mTOR inhibitor
    Based on the findings from Aim 1, the optimal drug (RAPA or EVERO), interval between doses, and dose for INTERMITTENT delivery will be tested in a blinded placebo-controlled trial in older human subjects. The drug/dose/interval used in males may differ from the one used in females as the OD will be determined independently for the two sexes. PD parameters 'downstream' from mTOR will be followed. Although drug is delivered on an intermittent schedule, subjects will be given a pill each day (either drug or placebo, as scheduled) to maintain blinding.
  • Placebo Comparator: Aim 2: Sub-study 3 Placebo control
    Daily administration of a placebo will be given to a cohort of older human subjects. Both males and females will be enrolled as controls.

Primary Outcome Measure

Pharmacokinetics (PK) of mTOR inhibitor in blood [ Time Frame: Baseline to study end (approximately 12 months for Aim 2; 12 weeks for Aim 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Dean L Kellogg Jr.,, MD PhD
[email protected]
210-617-5197
Dean L Kellogg Jr., MD PhD (PRINCIPAL_INVESTIGATOR)

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