JohnP, this is such a wonderful and unexpected early Christmas present!
If everything had stayed on script we might not have had this celebration for years.
It takes so many years for anything to happen that you start losing track of time.
But here we are and this might be before the FDA in a few months, it is startling.
And the benefits that we can see here are large.
The figures (admittedly this is for the early stage trial with smallish numbers) that I posted show about at least a 2 1/2 years stasis for decline in the high dose group. I cannot think of any other drug in the last 20 years that has had such a large population scale impact on quality of life. Breakthrough cancer drugs sometimes have survival benefits measured in weeks often with side effects. This is not weeks, this is years
and for patients who are otherwise healthy that means 2 1/2 years of more healthy living.
This is a substantial boost.
This is consistent with the impression that I have been forming over the last few years with taurx, Grifols, etc.. that there would be large benefits on the way for AD treatment. This is only the first wave which is focused on amyloid/tau. I wonder what happens when they stop the neurodegeneration and then add in a brain nutrient such Souvenaid, etc. To date I am not sure whether I can remember any strong clinical support for actually increasing cognitive functioning in those with clinical dementia, though I will be very excited when this is published. Combination treatment for Alzheimer's! It is hard to imagine that we have suddenly reached such a place.
The suggestion that the FDA is leaning towards more clinical evidence is a disappointment. I simply do not understand why they have talked about this for 7 months and then want more study. As soon as questions about the futility analysis were raised, trials should have immediately resumed. They couldn't have sorted out the answer without the trials; that is what they are for. If you don't know you need more empirical evidence not more rhetoric. Basically they debated it for all these months and then decided they needed more evidence. I do not understand why the FDA doesn't simply allow immediate marketing authorization as an amyloid lowering agent without efficacy claims which could be added later. Go back to the standard where safety has been demonstrated
and let people make up their own minds from there. The phase 3 Emerge result is very solid and it is consistent with a large body of research into amyloid; it can hardly be called a fluke. When you move beyond the topline results there will be undoubtedly be
highly dramatic results such as conditioning cognitive results on amyloid reduction that will amp up patient demand for quick approval.
Hopefully the word can get out there and people will realize that aducan is for everyone at a certain age, not just other people.
When we can clearly say that amyloid is a neurotoxin of the brain and that it is universally present in humans over 90, then the yardsticks of life can start to shift around.
NF52 is right that the big question of how to make the choice is beyond our knowledge base. However, one observation to keep in mind is that no Alzheimer drug has ever demonstrated efficacy until aducan; we have been waiting for millennia. Thus, the prior probability that any treatment will actually be effective is almost zero. If it were me, I would go amyloid lowering as this has shown effectiveness ( though it is a tough call that you will need to make yourself).
And with the gum issues, I am not clear why one could not receive the same benefits through diligent oral health. I have been using my waterflosser lately and my mouth feels much cleaner; possibly with less bacteria causing AD. You might want to read up on this further to check if this is consistent with the evidence gathered to date. For example, do they exclude patients from the trial if the y have excellent oral hygiene?
taurx is obviously another one to keep in mind. They have already posted very strong phase 3 results which they are now confirming. Would be highly worthwhile to look into methylene blue/LTMX. viewtopic.php?f=4&t=3890&p=45941&hilit=celebration#p45941