RECRUITING

MTOR Inhibitors in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .

Quick Facts

Study Start:2025-11
Study Completion:2027-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06727305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Community-dwelling adults
  2. 2. Patients should be 65 Years and older
  3. 3. Patients is able to understand and follow trial procedures
  1. 1. Creatinine clearance \<30 mL/min;
  2. 2. History of chronic liver disease;
  3. 3. Uncontrolled Hypertension (i.e., systolic blood pressure \>160 mm Hg);
  4. 4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
  5. 5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
  6. 6. Planned major surgical procedures;
  7. 7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);
  8. 8. Taking medication that increase or decrease sirolimus blood concentrations;
  9. 9. Other investigational therapy received within 1 month prior to screening visit;
  10. 10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.

Contacts and Locations

Study Contact

Irina Timofte, MD, MS
CONTACT
2163347534
Irina.Timofte@utsouthwestern.edu

Principal Investigator

Irina Timofte, MD, MS
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Irina Timofte, MD, MS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11
Study Completion Date2027-11-13

Study Record Updates

Study Start Date2025-11
Study Completion Date2027-11-13

Terms related to this study

Keywords Provided by Researchers

  • Aging
  • Geriatic
  • Disability

Additional Relevant MeSH Terms

  • Aging