Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05237687
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2022-01-19
Brief Title:
The Role of Sirolimus in Preventing Functional Decline in Older Adults
Sponsor:
Irina Timofte
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Sirolimus in Older Adults- Randomized Trial Assessing the Improvement in PhenotypicFunctional Biomarkers of Aging
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 PI3Kprotein kinase B AKTmammalian 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
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 PI3Kprotein kinase B AKTmammalian 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None