Clinical trials

Clinical trials will likely have to be a part of this competition.

    How can we make sure that the results of the trials are as scientifically compelling as possible? Are there any bodies other than the FDA that we should be working with to register and manage the trials?

@efoehr, @hjforman, @Fossel, @TinaWoods, you may have thoughts on this for us?

We are now in the process of designing an XPRIZE for Age Reversal, which is a direct outcome of the Future of Longevity Impact Roadmap to which you contributed last year. Please click here to learn more about this new prize design.

@Bronwen, @maxinemack, @Polina_veritas, you may be able to help us answer some of these questions as well. What do you think?

We will be intervening directly in the aging process at the cellular, genetic, and epigenetic levels in our upcoming FDA trials against Alzheimer’s disease.

For those who would like additional information, I suggest either my recent article (more than 600 global reprint requests in its first two weeks) or my Oxford University Press textbook on this topic Cells, Aging, and Human Disease. Reversing aging is quite feasible, but it requires that you actually UNDERSTAND the aging process. The article is now free access at: https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12012

When I was thinking about an answer for other topic (the topic about “how many years of rejuvenation should bet set as a goal for the prize”), one of the reasons which made me suggest “more than 15 years” was exactly that this would allow for people TO SEE WITH THEIR OWN EYES the rejuvenation. If we set a goal of, let’s say, 7 years, it could be more feasible, but 7 years aren’t necessarily something super-obvious in terms of physical aspect. However, more than 15 years will be super-obvious. Then, the conversation about the importance of clinical trials depends of that goal: a goal of 5 or 7 years of rejuvenation makes the clinical trials way more important than a goal of more than 15 years. In fact, I think that if some entity rejuvenates people more than 15 years, an epigenetic regular measurement such as the classic Horvath epigenetic clock will be enough. Maybe a combination of epigenetic clocks could be an option.

@MFossel - Thank you for the link! Could you direct us to your trial, assuming it’s registered already with the FDA? Or simply tell us more about it?

We’ve talked with CBER/FDA in Washington, but the trial is not yet registered. The trial will be a six-month trial using a single-dose therapy, with neuropsych, imaging, and lab studies. The protocol has been vetted by several experienced researchers who 1) ran the first successful gene therapy trial in the US, 2) designed the Biogen/Eisai Alzheimer’s trials, and 3) have run multiple FDA Alzheimer’s human trials as the PI. We have generally avoided media attention and will continue to focus on: 1) credibility, 2) safety, 3) efficacy, and 4) costs.

In addition to the FDA, you will need an IRB to approve and monitor clinical trials. While universities have IRBs, it will probably be easier to work with a commercial central IRB.