Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2026-02-28
2027-11-13
Brief Summary
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Detailed Description
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Specific Aims:
Aim 1: To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors (sirolimus and everolimus) in older adults.
Aim 2: To determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up.
Exploratory Aim 3: We will also assess the feasibility of collecting the laboratory biomarkers (ESR, CRP, S6K activity, mitochondrial function, metabolomics) and data regarding the functional biomarkers of aging measured by walking speed, chair stand, standing balance, grip strength
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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sirolimus 0.5 mg Arm
Participant would receive 0.5 mg of sirolimus.
Sirolimus 0.5 Mg Oral Tablet
Sirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
sirolimus 1 mg Arm
Participant would receive 1 mg of sirolimus.
Sirolimus 1Mg Oral Tablet
Sirolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
sirolimus 2 mg Arm
Participant would receive 2 mg of sirolimus.
Sirolimus 2 MG Oral Tablet
Sirolimus 2 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
everolimus 0.5 mg Arm
Participant would receive 0.5 mg of Everolimus.
Everolimus 0.5 MG Oral Tablet
Everolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
everolimus 1 mg Arm
Participant would receive 1 mg of Everolimus.
Everolimus 1 MG Oral Tablet
Everolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
everolimus 2 mg Arm
Participant would receive 2 mg of Everolimus.
Everolimus 2 MG Oral Tablet
Everolimus 2 mg oral tablets for daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Interventions
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Sirolimus 0.5 Mg Oral Tablet
Sirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 1Mg Oral Tablet
Sirolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 2 MG Oral Tablet
Sirolimus 2 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 0.5 MG Oral Tablet
Everolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 1 MG Oral Tablet
Everolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 2 MG Oral Tablet
Everolimus 2 mg oral tablets for daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Eligibility Criteria
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Inclusion Criteria
2. Patients should be 65 Years and older
3. Patients is able to understand and follow trial procedures
Exclusion Criteria
2. History of chronic liver disease;
3. Uncontrolled Hypertension (i.e., systolic blood pressure \>160 mm Hg);
4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
6. Planned major surgical procedures;
7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);
8. Taking medication that increase or decrease sirolimus blood concentrations;
9. Other investigational therapy received within 1 month prior to screening visit;
10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.
65 Years
80 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
National Institute on Aging (NIA)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Irina Timofte
Associate Professor
Principal Investigators
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Irina Timofte, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU-2024-0798
Identifier Type: -
Identifier Source: org_study_id
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