Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 10:40 AM
Study NCT ID:
NCT06658093
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESTOR: PK/PD mTORi Inhibition in Older Adults
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTOR
Brief 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.
Detailed 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 measure mTOR activity in young untreated subjects to define these target "youthful" mTOR activity levels.
Sub-study 2. Finding the most effective drug, dose, and timing for dosing for oral dosing of the mTOR inhibitor drugs in older adults (65-90 years):
Healthy older persons will be recruited for a short-term (6 week treatment plus 4 week follow-up) dose-finding study. The most effective, but safe dose will then be tested in a larger number of subjects in Sub-study 3. Importantly, the best drug and dose regimen for females may differ from the one determined for males so the cohort will include both sexes.
Sub-study 3. Placebo controlled trial testing of DAILY (sustained) vs. INTERMITTENT mTOR inhibition in older human males and females:
Sub-study 3 will enroll healthy older persons (65-90 yrs) for a long-term clinical trial (6 months of treatment plus 6 months of follow-up) with 3 test groups:
i) best DAILY dose/drug; ii) best INTERMITTENT dose/drug/interval, and iii) PLACEBO (a pill that looks identical to the medicine, but has no drug in it).
This study will help find out what effects, good and/or bad, Rapamycin or Everolimus have on older people who take the drug for a longer period of time. The safety of Rapamycin and Everolimus in humans has been tested in prior research studies; however, some side effects may not yet be known in healthy older persons. By completing the entire study, the Research Team hopes to learn more about how older human subjects can best be treated using these drugs (mTOR inhibitors) to help them live longer, healthier lives.
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 measure mTOR activity in young untreated subjects to define these target "youthful" mTOR activity levels.
Sub-study 2. Finding the most effective drug, dose, and timing for dosing for oral dosing of the mTOR inhibitor drugs in older adults (65-90 years):
Healthy older persons will be recruited for a short-term (6 week treatment plus 4 week follow-up) dose-finding study. The most effective, but safe dose will then be tested in a larger number of subjects in Sub-study 3. Importantly, the best drug and dose regimen for females may differ from the one determined for males so the cohort will include both sexes.
Sub-study 3. Placebo controlled trial testing of DAILY (sustained) vs. INTERMITTENT mTOR inhibition in older human males and females:
Sub-study 3 will enroll healthy older persons (65-90 yrs) for a long-term clinical trial (6 months of treatment plus 6 months of follow-up) with 3 test groups:
i) best DAILY dose/drug; ii) best INTERMITTENT dose/drug/interval, and iii) PLACEBO (a pill that looks identical to the medicine, but has no drug in it).
This study will help find out what effects, good and/or bad, Rapamycin or Everolimus have on older people who take the drug for a longer period of time. The safety of Rapamycin and Everolimus in humans has been tested in prior research studies; however, some side effects may not yet be known in healthy older persons. By completing the entire study, the Research Team hopes to learn more about how older human subjects can best be treated using these drugs (mTOR inhibitors) to help them live longer, healthier lives.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01AG089242 | NIH | None | https://reporter.nih.gov/quic… | View |