Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835999
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-04-03
Brief Title:
Everolimus Aging Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Clinical Evaluation of mTORC1 Inhibition for Geroprotection
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERLAST
Brief Summary:
The objective of this project is to determine if mTORC1 inhibition by 24 weeks of daily 05 mgday or weekly 5 mgweek everolimus can safely improve physiological and molecular hallmarks of aging in humans Participants who are 55-80 years old and insulin resistant or prediabetic will be randomized to treatment and can expect to be on study for up to approximately 38 weeks Participants aged 18-35 will not receive the intervention and can expect to be on study for up to approximately 8 weeks
Detailed Description:
Pharmacological inhibition of mechanistic target of rapamycin mTOR has been repeatedly demonstrated to extend lifespan and prevent or delay several age-related diseases in diverse model systems However the risk of potentially serious side effects in humans have thus far prevented the long-term use of the mTOR inhibitor rapamycin as a therapy for aging and age-related diseases Therefore it remains unknown whether rapamycin or rapamycin analogs rapalogs can safely improve healthy aging in humans
The objective of this project is to determine if 24 weeks of daily low dose 05 mgday or weekly intermittent 5 mgweek treatment with the rapalog everolimus can safely improve physiological and molecular hallmarks of aging in middle-aged to older insulin resistant adults who are at high risk for nearly every age-related condition
Using a double-blinded randomized placebo-controlled clinical trial the investigators will perform a battery of gold-standard and innovative techniques to test the hypothesis that daily low dose or weekly everolimus treatment will improve 4 inter-related domains of physiological aging metabolic cardiac cognitive and physical function The investigators will also assess the incidence of adverse events and changes from baseline blood chemistry blood cell counts lipids glucose and insulin
To comprehensively examine the molecular target specificity and the impact on mechanisms of aging by everolimus the team will evaluate mTORC1 and mTORC2 signaling assess mitochondrial bioenergetics and perform a multi-omics approach epigenomics transcriptomics proteomics lipidomics and metabolomics in blood andor muscle biopsy samples
The objective of this project is to determine if 24 weeks of daily low dose 05 mgday or weekly intermittent 5 mgweek treatment with the rapalog everolimus can safely improve physiological and molecular hallmarks of aging in middle-aged to older insulin resistant adults who are at high risk for nearly every age-related condition
Using a double-blinded randomized placebo-controlled clinical trial the investigators will perform a battery of gold-standard and innovative techniques to test the hypothesis that daily low dose or weekly everolimus treatment will improve 4 inter-related domains of physiological aging metabolic cardiac cognitive and physical function The investigators will also assess the incidence of adverse events and changes from baseline blood chemistry blood cell counts lipids glucose and insulin
To comprehensively examine the molecular target specificity and the impact on mechanisms of aging by everolimus the team will evaluate mTORC1 and mTORC2 signaling assess mitochondrial bioenergetics and perform a multi-omics approach epigenomics transcriptomics proteomics lipidomics and metabolomics in blood andor muscle biopsy samples
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 1192024 | OTHER | UW Madison | httpsreporternihgovquickSearch1U01AG076941-01 |
| 1U01AG076941-01 | NIH | None | None |
| A534255 | OTHER | None | None |