MTOR Inhibitors in Older Adults

ConditionAging
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65-80
SponsorUniversity of Texas Southwestern Medical Center

About 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

Eligibility criteria

Qualifiers

Community-dwelling adults

Patients should be 65 Years and older

Patients is able to understand and follow trial procedures

Disqualifiers

Creatinine clearance <30 mL/min;

History of chronic liver disease;

Uncontrolled Hypertension (i.e., systolic blood pressure >160 mm Hg);

Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;

Trial design

Treatments tested in this trial

  • Sirolimus 0.5 Mg Oral Tablet
  • Sirolimus 1Mg Oral Tablet
  • Sirolimus 2 MG Oral Tablet
  • Everolimus 0.5 MG Oral Tablet
  • Everolimus 1 MG Oral Tablet
  • Everolimus 2 MG Oral Tablet

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

University of Maryland, Baltimore

Collaborator

National Institute on Aging (NIA)

Collaborator