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mTOR Inhibitor

Rapamycin + Everolimus for Aging (RESTOR Trial)

Phase < 1

Waitlist Available

Led By Ellen Kraig, PhD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥65 to 90 years

Be older than 65 years old

Must not have

History of severe head trauma, brain injury, brain surgery, inflammation of the brain, or history of seizures

Diagnosis of any disabling neurologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study end (approximately 12 months for aim 2; 6 weeks for aim 1)

Summary

"This trial aims to test two drugs, Rapamycin and Everolimus, in older adults to see if they can slow down the aging process and improve health. The researchers want to find the right

Who is the study for?

This trial is for healthy older adults interested in participating in a study that aims to slow down the aging process. The focus is on finding safe dosages of drugs called mTOR inhibitors, which might help reduce age-related issues. Both men and women are encouraged to join.

What is being tested?

The RESTOR trial is testing two mTOR inhibitor drugs, Rapamycin and Everolimus, against a placebo to see if they can safely mimic the cellular conditions of younger individuals in older adults, potentially slowing aging.

What are the potential side effects?

Possible side effects from Rapamycin or Everolimus may include mouth sores, increased risk of infections due to a weakened immune system, high cholesterol levels, skin rashes, and lung or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 65 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe head trauma, brain surgery, or seizures in the past.

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I have been diagnosed with a disabling neurological condition.

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I am not taking medication that affects cytochrome P450.

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I have diabetes or am taking medication to lower my blood sugar.

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I have had skin ulcers or issues with wounds not healing well.

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I have had long-term symptoms after recovering from COVID-19.

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I have a history of serious heart or lung disease.

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My cholesterol or triglyceride levels are not higher than 350mg/dl and 500mg/dl, respectively.

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I have moderate to severe heart valve disease.

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I have a blood clotting disorder or need blood thinners.

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My kidney function is low, with a filtration rate under 30ml/min.

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I have not had COVID-19 in the past 6 months.

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I am currently on hormone therapy.

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I have had a recent heart attack or have ongoing heart problems.

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I have been treated for cancer or had cancer in the last 5 years.

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I am currently using CBD or THC products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study end (approximately 12 months for aim 2; 6 weeks for aim 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study end (approximately 12 months for aim 2; 6 weeks for aim 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study end (approximately 12 months for aim 2; 6 weeks for aim 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

PD measure of inhibition of mTOR activity in PBMCs Akt

PD measure of inhibition of mTOR activity in blood cells pS6K

+1 more

Secondary study objectives

PD measure of inhibition of mTOR activity in PBMCs, rpS6

PD measure of inhibition of mTOR activity in adipose (fat) cells Akt (Aim 2 only)

PD measure of inhibition of mTOR activity in adipose cells, rpS6 (Aim 2 only)

+6 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Aim 2: Sub-study 3 Optimized INTERMITTENT Dosing of an mTOR inhibitorExperimental Treatment2 Interventions

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.

Group II: Aim 2: Sub-study 3 Optimized DAILY Dose of an mTOR inhibitorExperimental Treatment2 Interventions

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.

Group III: Aim 1:Sub-study 2 Intermittent dosing Cohort RapamycinExperimental Treatment1 Intervention

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.

Group IV: Aim 1:Sub-study 2 Daily dosing Cohort RapamycinExperimental Treatment1 Intervention

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.

Group V: Aim 1: Sub-study 2 Intermittent dosing Cohort EverolimusExperimental Treatment1 Intervention

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.

Group VI: Aim 1: Sub-study 2 Daily dosing Cohort EverolimusExperimental Treatment1 Intervention

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.

Group VII: Aim 2: Sub-study 3 Placebo controlPlacebo Group1 Intervention

Daily administration of a placebo will be given to a cohort of older human subjects. Both males and females will be enrolled as controls.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

2010

Completed Phase 4

~1510

Rapamycin

2008