NCT04742777

Effect of mTOR Inhibition & Other Metabolism Modulating Interventions on the Elderly [SubStudy Rapa & cMRI to Evaluate Cardiac Function]

Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly: Immune, Cognitive, and Functional Consequences ((Substudy E - RAPA cMRI With LGE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 70 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95). Substudy E will evaluate the Rapamycin and Cardiac Function.

Detailed description

The main study has completed and results are reported (NCT02874924) Purpose of Sub-study E - Rapamycin and cMRI to evaluate cardiac function: The over-arching hypothesis is that RAPA treatment will effect simultaneous improvement in parameters known to be negatively impacted by aging. For example, systemic inflammation is higher in older individuals and contributes to the development of age-related pathologies affecting both the heart and the vasculature. In particular, evidence indicates that aging-associated alterations in inflammatory and pro-fibrotic pathways are critically involved in the etiology of age-related declines. The study team hypothesize that mTOR antagonism with RAPA will improve detrimental age-related pathologies affecting the heart in elderly humans.

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	rapamycin	Taken orally 1mg daily for 8 weeks

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-09-09
• Completion: 2025-09-09
• First posted: 2021-02-08
• Last updated: 2025-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study