Using Sirolimus to Prevent Functional Decline in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of sirolimus, an immunosuppressive drug, to prevent functional decline associated with aging in adults aged 65 to 80. The study aims to explore how sirolimus affects the mTOR signaling pathway, which is linked to various age-related diseases and conditions. By targeting this pathway, the trial seeks to identify a new therapeutic intervention that could mitigate the degenerative processes of aging. Participants will be closely monitored for changes in their functional abilities and overall health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients should be adults 65-80 years
* Women who are postmenopausal\* or status post-surgical sterilization only
* Competent to provide Informed Consent

Exclusion Criteria:

* Creatinine clearance \<30 mL/min
* Underlying chronic liver disease
* Other investigational therapy received within 1 month prior to screening visit
* Pulmonary Arterial Hypertension (PAH), mean Pulmonary Arterial Presure(mPAP)\>30 mm Hg
* Extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
* Cardiovascular diseases, any of the following: Myocardial infarction within 6 months, planned coronary artery disease intervention , left ventricular EF \<45%

  * History of haemorrhagic central nervous system (CNS) event within 1 year from screening visit.
  * Any of the following within 3 months of screening visit :Haemoptysis or haematuria;Active gastro-intestinal (GI) bleeding or GI - ulcers; Major injury or surgery
* History of thrombotic event (including, DVT, PE, stroke and transient ischemic attack) within 1 year from screening visit.
* Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
* Planned major surgical procedures.
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
* Concurrent active alcohol or drug abuse.
* Clinically significant cognitive impairment
* Functional impairment (defined by ADL status)
* Patients not able to understand or follow trial procedures

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Irina Timofte, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: Irina Timofte
• Email: Irina.Timofte@utsouthwestern.edu
• Phone: 2163347534

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.