The Next Step in Rapamycin Human Clinical Trials?

#1

I’m in early discussions with some academic researchers who have experience with animal testing of longevity drugs. We all know that we need much more in the way of rigorous human clinical trials for rapamycin in longevity, but the question is how best to go about getting these studies going…

The following idea was brought up, what do you think about it? Do you think we could get enough people participating? Perhaps the crowd here in this forum are not the target market for this type of clinical trial - many, if not most, people here are already convinced of Rapamycin’s likely merits and are using it already. I didn’t want to join the PEARL study because I might have to stop taking rapamycin and be placed on the placebo.

But there is a vast number of people who are interested, but have not yet tried rapamycin. Perhaps this study would be for many of them? Please post your thoughts on this idea.

If there are hundreds of people who cooperate, a double-blind cross-over study would be powerful.

Divide them into two groups matched as well as possible for age (perhaps limited to people 50-70 years old), sex, size, basic health, etc.

Give one group the drug, the other the placebo, but NO one except the experiment designer knows which is which.

Importantly BOTH patients and those evaluating them are blinded to avoid prejudice.

Measure after an appropriate interval (1 year? 5 years?).

Crossover - Switch the drug and placebo groups and repeat.

A serious problem is duration of studies needed for people.

One year may not be enough to see ANY real changes relevant to aging.

Thus a longer interval (5 years) might be more useful. BUT is it practical?

1 Like
#2

Human trials are essential but the primary endpoint almost has to be a lifespan extension. Otherwise you’ll just have improved biomarkers relating to immunity, inflammation, cardiac ejection fraction , among others, and it will be argued that rapamycin just improves health .
Furthermore, the naysayers will point to lipids and say that since it’s increasing cardiovascular risk that the risks exceed the benefits.

I’m afraid the only answer is to give it to 60 year olds and see if they live longer, even though it’s not very practical. If they did then who cares about the mouth sores and lipids.

It can’t just be a healthspan study.

5 Likes
#3

Possibly a study similar to Tame for metformin could provide some evidence of life extension. Comparing mortality rates of 2 groups of 60 year old people, one taking rapamycin and one not taking it, over 5 or 10 years could provide some valuable information

1 Like
#4

Really nice to just copy the TAME structure and use it for rapamycin. I like it! Lets call it TARA (=Target Aging with RApamycin)

1 Like