UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
Location contact
Irina Timofte
CONTACT
NCT Number: NCT05237687
Aging is associated with progressive impairment of tissue and organ function, resulting in increased susceptibility to chronic disease, frailty and disability. Currently there are limited treatment options to alter this inevitable process. The proposed work has the potential to identify a new therapeutic intervention to decrease aging-related degenerative processes.
Rapamycin or sirolimus is a macrocyclic immunosuppressive drug that inhibits the mammalian target of rapamycin (mTOR). The mammalian target of rapamycin (mTOR) pathway is part of phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR)-dependent pathway which is a fundamentally linked to cell metabolism, proliferation, differentiation, and survival. This pathway is altered in a variety of diseases, including cancers, immunosuppressed states, and fibroproliferative diseases. The mTOR kinase is considered one of the leading regulators of this pathway. Changes in mTOR signaling are closely associated with inflammation, cell growth and survival, leading to the development of chronic diseases. Recent evidence also suggests that mTOR inhibitors are promising modulators of the aging process by slowing the mechanisms of aging at the cellular level. There is a growing appreciation of the potential impact of sirolimus in slowing aging processes and in prolonging healthy lifespan.
The proposed study addresses critical gaps in our understanding of the safety and efficacy of sirolimus in delaying aging processes and is based on findings in animal studies and incidental clinical observations. The investigators will overcome potential biases with a randomized control trial. The proposed intervention study is intended to improve our insight into clinical outcomes leading to prevention of chronic diseases such as skin cancer and mortality. Our overarching hypothesis is that sirolimus is one of the first pharmacological agents that will impact the aging process and chronic disease development. Specifically, the investigators aim to investigate whether sirolimus can reduce the occurrence or increase in biomarkers of aging processes.
Interested in participating?
Request Info65 year–80 year
All sexes
Interventional
Phase 2
Dallas, Texas, 75390, United States
Location status: Recruiting
Irina Timofte
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be randomly assigned to sirolimus or standard of care
Time frame: 1 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.
Time frame: 1 year
Phenotypic/functional biomarkers of aging will be measured by walking speed at 1 year follow-up when compared to elderly patients not receiving sirolimus.
Time frame: 1 year
Functional biomarkers of aging will be measured by chair stand at 1 year follow-up when compared to elderly patients not receiving sirolimus.
Time frame: 1 year
Functional biomarkers of aging will be measured by standing balance at 1 year follow-up when compared to elderly patients not receiving sirolimus.
Time frame: 1 year
Phenotypic/functional biomarkers of aging will be measured by body mass index at 1 year follow-up when compared to elderly patients not receiving sirolimus.
Time frame: 1 year
The feasibility of collecting the laboratory biomarkers and analyzing the data regarding annual rate of decline in functional biomarkers of aging measured by walking speed, chair stand, standing balance, grip strength, body mass index, waist circumference, and muscle mass.
Contact information is provided by the study sponsor or research team.
Irina Timofte
Other
Sirolimus in Older Adults- Randomized Trial Assessing the Improvement in Phenotypic/Functional Biomarkers of Aging
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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