Summary
“The overall hypothesis we wish to investigate is whether periods of time where the mechanistic target of Rapamycin (mTOR) pathway is activated via exercise, combined with alternate periods of time where mTOR is inhibited using Sirolimus (Rapamycin), will result in greater muscle performance in older adults compared with just exercise alone." - Dr. Brad Stanfield.
It is proposed that VitaDAO provide $50,000 USD (1/8th of the project budget) and look to activate our community to solicit more funding.
Motivation
VitaDAO, recognizes the importance of credible science in the field of healthspan and longevity research. One aspect of current longevity research that remains challenging is the translation of research from model organisms to humans, and the clinical trials regime that is imposed on new interventions.
There is a view that a number of currently approved drugs - those that have long since completed the regulatory hurdles - have shown observable, incremental effects on longevity. One such drug is Rapamycin.
Rapamycin is an approved drug for prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. The proposed study is meant to establish whether intermittent Rapamycin use demonstrates a functional improvement in frailty and sarcopenia endpoints.
Specification
The clinical study will be lead by Dr. Brad Stanfield.
Dr. Brad Stanfield is a Medical Doctor at the Tuakau Health Centre in New Zealand having completed his residency at Auckland DHB.
In 2019, he started his YouTube channel to discuss the state of longevity science with an emphasis on explaining peer-reviewed scientific papers in easy-to-understand language, but also with a focus on providing proper limits to the science and discouraging claims which exceed the evidence.
With a community of over 98,000 followers, Dr. Stanfield has become a recognized and credible voice in the communications of longevity science.
Why another Rapamycin trial?
As a Phase 2a trial in humans - focused on functional improvements in sarcopenia - this study will support our understanding of Rapamycin impacts on aging related decline in physical function, but also work towards establishing a framework for regulatory approval of interventions that are preventative in nature related to aging.
The clinical trial protocol can be found here.
In contrast to the ongoing PEARL trial for rapamycin and aging (NCT04488601), this proposed trial will measure muscle power and strength by combining rapamycin intake with an exercise regimen. The primary outcome for this proposed trial is the 30-second chair test, which is a robust and clinically relevant marker of performance. In addition, several secondary outcomes will be measured including but not limited to: community balance and mobility, hand grip strength, 6-minute walk test, DNA methylation age, and serum levels of NAD+, cholesterol, and S6K. Importantly, this Phase 2 study is not powered enough to say that rapamycin + exercise is better than exercise alone, instead it will be used to determine safety and some preliminary results. This proposed trial will be a stepping stone to a much larger study involving ~400-500 individuals.
Implementation
Though there is no immediate intellectual property for VitaDAO from this project, our support is intended to advocate for further research into off-label use of approved, off-patent drugs and show our support for innovative and crowdsourced funding of research.
This is complementary to VitaDAO’s support of CrowdFundedCures.org, and the social impact bond model in VDP-17.
Dr. Stanfield has developed a strong following on YouTube for his informative and well researched videos on healthspan related interventions and science, and is an asset to the longevity community and we wish to signal our support for this research with the intention of supporting Dr. Stanfield to raise the needed funds for the trial.
Budget:
The budget for the clinical trial is $400,000. It is suggested that VitaDAO would provide $50,000 USD (1/8th of the project budget) and look to activate our community to solicit more funding. In the United States, Lifespan.io is supporting the fundraising for the trail as a 501(c)3 charity.
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