mTOR Inhibitors for Aging

Overseen By Irina Timofte, MD, MS

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Sirolimus modifiers

Disqualifiers: Chronic liver disease, Uncontrolled hypertension, Cardiovascular diseases, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications

Who Is on the Research Team?

Irina Timofte, MD, MS

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for community-dwelling adults aged 65 and older who can understand and follow the trial procedures. It aims to explore how certain medications might affect aging, but details on exclusion criteria are not provided.

Inclusion Criteria

I live in my own home or with family.

I am 65 years old or older.

I can understand and follow the trial's instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mTOR inhibitors (sirolimus or everolimus) to assess pharmacokinetics and pharmacodynamics

3 months

Multiple visits for blood sampling and biomarker assessment

Follow-up

Participants are monitored for changes in phenotypic biomarkers of aging and safety

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Everolimus
• Sirolimus

Trial Overview The study tests different doses of mTOR inhibitors (Sirolimus and Everolimus) in tablet form to gather data on their effects in older adults. This could lay the groundwork for future trials on slowing aging processes.

How Is the Trial Designed?

Group I: sirolimus 0.5 mg Arm Active Control 1 Intervention

Participant would receive 0.5 mg of sirolimus.

Group II: sirolimus 1 mg Arm Active Control 1 Intervention

Participant would receive 1 mg of sirolimus.

Group III: everolimus 0.5 mg Arm Active Control 1 Intervention

Participant would receive 0.5 mg of Everolimus.

Group IV: everolimus 2 mg Arm Active Control 1 Intervention

Participant would receive 2 mg of Everolimus.

Group V: sirolimus 2 mg Arm Active Control 1 Intervention

Participant would receive 2 mg of sirolimus.

Group VI: everolimus 1 mg Arm Active Control 1 Intervention

Participant would receive 1 mg of Everolimus.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+