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Sirolimus for Preventing Functional Decline in Older Adults

This study is looking at whether a drug called sirolimus can help prevent the decline in body function that often comes with aging. Researchers want to see if sirolimus can reduce problems like frailty and disability. You might be able to join if you are between 65 and 80 years old, and women must be past menopause or have had surgical sterilization. You cannot join if you have certain kidney or liver conditions, or if you've recently received other experimental treatments. Participants will be randomly assigned to either receive sirolimus or standard care. The study will measure how well your body functions after one year to see if sirolimus has an effect.

Study design
This is an interventional study planning to enroll 10 participants. Participants will be randomly assigned to receive either sirolimus or standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05237687

The Role of Sirolimus in Preventing Functional Decline in Older Adults

Recruiting
PHASE2Ages 65–80InterventionalPrevention
Irina Timofte
~10 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Sirolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phenotypic/functional biomarkers of aging
Measured over 1 year

Conditions

Aging

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NCT05237687

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UT Southwestern Medical Center

    Dallas, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Irina Timofte, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Irina Timofte
[email protected]
2163347534
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Phenotypic/functional biomarkers of aging1 year

    Phenotypic biomarkers of aging will be measured by SASP (senescence-associated secretory phenotype) index score at 1 year follow-up when compared to elderly patients not receiving sirolimus.