Off Label Use

"Perfect is the enemy of good".

The use of rapamycin to prevent AD in carriers of APOE4 allele is "off-label".

Perfect is not "off-label". Perfect is sufficient clinical data is amassed in human clinical trials to prove to the FDA that a particular treatment is both safe and efficacious. There is no dispute, everybody loves perfect.  

There are now 20 million Americans in the 40-70 age group who are APOE4 carriers and are at very high risk of AD at a relatively young age. No prophylactic treatment is being provided to this group. This is very far from perfect; this is a medical emergency. 

In the past 10 years compelling fact-based scientific evidence has emerged, presented in detail in the body of this website, that there is a very substantial chance rapamycin, used as a intermittent, weekly dose will lower the risk of development of AD in this high risk group.

For a number of reasons, the most important being, in my opinion, that rapamycin is a generic drug, the likelihood of data from human clinical trials in the foreseeable future, is problematic. 

I have acquired substantial experience in the intermittent, weekly use of rapamycin, and in my opinion, rapamycin, so used, has an acceptable safety profile with proper monitoring. 

I therefore have made intermittent weekly rapamycin available in my medical practice for APOE4 carriers. This website provides detailed information regarding the scientific studies which form the basis of offering rapamycin for prevention of AD in APOE4 carriers.

It is my opinion, that those at greatest risk have the right to decide for themselves which is better; "the devil you know, or the devil you don't know." 

All prospective patients are strongly encouraged to study the material; so that they can make a proper and intelligent INFORMED CONSENT; if they elect rapamycin-based "off-label" treatment.