Clinical Trial - Regular Exercise & Intermittent Rapamycin Dosing

Background

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 trial 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 human clinical trial is meant to establish whether intermittent Rapamycin use demonstrates a functional improvement in frailty and sarcopenia endpoints.

‍Aims, Hypothesis & Results

Rapamycin is a best-in class-treatment, meaning it provides one of our strongest chances of seeing healthspan improving effects - yet surprisingly, few human trials have tested its healthspan effects.

As a Phase 2a trial in humans - focused on functional improvements in sarcopenia - this study will support our understanding of Rapamycin impacts on ageing related decline in physical function, but also work towards establishing a framework for regulatory approval of interventions that are preventative in nature related to ageing.

The clinical trial protocol can be found here:
https://drive.google.com/file/d/1AP1L9JjGdnZgFmZ4sEDCWnp_2-g70-SP/view

In contrast to the ongoing PEARL trial for rapamycin and ageing (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.

‍Timeline

Dr. Brad Stanfield is planning to conduct a Phase 2a clinical trial to test the effect of rapamycin on age-related frailty and sarcopenia. The trial includes recruitment and data analysis, and the results of the trial will be used to determine safety and some preliminary results. The hope is to make the trial a stepping stone to a much larger study involving 400–500 individuals.

Phase 2a Clinical Trial: Regular Exercise & Intermittent Rapamycin Dosing
Required Funding: $400,000
Duration: 13 weeks

VitaDAO Board Evaluation Writeup

Dr. Brad Stanfield is a medical doctor who 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.

There is a large amount of literature from numerous organisms showing that rapamycin treatment can lead to improvements in healthspan/lifespan. This trial, aiming to test the effect of rapamycin on age-related frailty and sarcopenia, has a robust study protocol with the potential to lead to a more rigorous phase 3 trial.

The budget for the clinical trial is $400,000. VitaDAO will 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 trial as a 501(c)3 charity.

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.