University of Arizona Launches $12 Million Phase 3 Trial Testing Rapamycin for Healthy Aging
核心洞察
The University of Arizona will begin a double-blind, randomized Phase 3 clinical trial to evaluate whether rapamycin can improve resilience and immune function in older adults.
The six-year study is funded by $12 million in philanthropic support from alumnus R. Ken Coit and will test low-dose rapamycin in participants aged 65 and older.
Researchers will measure rapamycin's impact on physical function and frailty (搜索) transition, as well as its ability to reduce IL-6 inflammatory markers associated with age-related diseases.
Researchers at the University of Arizona R. Ken Coit College of Pharmacy will begin a groundbreaking double-blind, randomized Phase 3 clinical trial this year to evaluate whether rapamycin, a drug traditionally used to prevent organ transplant rejection, can improve older adults' resilience and immune function. The ambitious study represents the first investigator-led clinical trial in the College of Pharmacy and is funded with $12 million in philanthropic support from alumnus R. Ken Coit.
Trial Design and Timeline
According to lead investigator Bonnie LaFleur, a professor in the Coit College of Pharmacy, the Phase 3 clinical trial is projected to take six years, pending final FDA approval. The study design includes participants randomized to receive either rapamycin or placebo for two years, followed by an additional year of follow-up monitoring. Collaborators will conduct several ancillary studies in parallel with the main clinical trial, all focused on improving health and well-being in older adults.
"This study will measure the ability for low-dose rapamycin to maintain or improve physical and immunologic functioning in people 65 years and older," explained Coit, who graduated from the College of Pharmacy in 1967.
Primary Endpoints and Biomarkers
Researchers will focus on two main measures to evaluate rapamycin's potential effects. The first endpoint will assess the drug's impact on physical function, specifically examining whether rapamycin can alter the transition to frailty (搜索), a condition that significantly impacts quality of life in older adults. The second primary measure will evaluate levels of IL-6, an inflammatory marker associated with many age-related diseases, including frailty. The research team aims to determine if rapamycin can reduce IL-6 levels in the blood.
Scientific Rationale
The trial builds on existing evidence supporting rapamycin's potential in aging research. "Several studies have proven that rapamycin can improve vaccine efficacy and improve oral health in older adults," Coit noted. "Rapamycin is our best shot on goal for improving resiliency and healthspan as we age."
The study is conducted through the Coit Center for Longevity and Neurotherapeutics, established in 2023 within the College of Pharmacy. The center's research efforts span from improving understanding of neurodegenerative disorders such as Alzheimer's disease (搜索) and Parkinson's disease (搜索) to uncovering new drug targets and developing therapies that could modify aging and disease processes.
Institutional Support and Impact
"Ken's generosity is making possible the first investigator-led clinical trial in the College of Pharmacy," said Brian Erstad, interim dean of the Coit College of Pharmacy. "His latest gift will enable new opportunities for our researchers to continue to gain further insights into the human lifespan and make new inroads in the development of therapeutics to slow aging."
University of Arizona President Suresh Garimella emphasized the broader implications of the research: "We are grateful to Ken for his latest gift which will empower a new approach to examining what aging and longevity mean, and hopefully lead to solutions to a better and more fulfilling life for many."
The philanthropic funding represents part of Coit's substantial commitment to the university. In 2021, his $50 million naming gift commitment established endowed faculty positions and student scholarships while renovating the Coit History of Pharmacy and Health Sciences Museum. The Coit Family Foundation has committed over $75 million since 2017 as part of the university's $3 billion Fuel Wonder campaign.