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Finally a drug that shows cognitive improvement
Posted: Sunday, May 8, 2022 9:51 AM
Joined: 1/12/2022
Posts: 10

For everyone out there who has a relative with moderate AD, I encourage you to apply for the Simufilam trials. Different caregivers (doctor and lawyer) give the same testimony about their relative improving thanks to the drug called Simufilam.

More than 100 sites are participating in the P3 trials. 


Posted: Sunday, May 8, 2022 4:04 PM
Joined: 2/26/2016
Posts: 287

Cassava Sciences (simufilam) announced in February that the FDA may put their trials on hold. Other sources indicate that they are misrepresenting their research. If you own stock in this company, it may be a good time to sell.

Lane Simonian
Posted: Sunday, May 8, 2022 4:41 PM
Joined: 12/12/2011
Posts: 5158

I will repeat what I posted on the caregiver's forum.

This is one of the more divisive drugs in the history of Alzheimer's disease.  Companies often list the possibility of the FDA putting drugs on clinical hold in their financial statements as a hypothetical situation, but Cassava Sciences disclaimer seemed rather defensive.  Maybe that is because it has been subject to all sorts of allegations from manipulating Western blots, to removing an outlier to make a failed drug trial look successful, to manipulating cognitive test numbers.  I think the investigations into the company are going to produce mixed results. p.40.

I don't think the company has the right mechanism of action because when it is stripped down it is still an anti-amyloid drug (restoring filamin A to its original form in order to reduce amyloid binding to various receptor).  There are other mechanisms of action, though, that potentially explain simufilam's improvements in cognitive function at one year.

In small, open label trials, Anavex 2-73 (blarcamesine) and panax ginseng/Korean red ginseng have produced better results than simufilam at one year.  If Cassava Sciences is able to replicate its open label trial in phase 3 clinical trials than it will be better than the current standard of care, but probably not the best treatment for Alzheimer's disease ever.

Posted: Thursday, May 26, 2022 11:04 AM
Joined: 1/25/2020
Posts: 7

I'm sorry, Lane, are you proposing that you know more about the mechanism of action of this drug than the company that developed it and has been studying it intensely for years?
Lane Simonian
Posted: Thursday, May 26, 2022 1:11 PM
Joined: 12/12/2011
Posts: 5158

Several scientists have said that the mechanism of action proposed by Cassava Sciences is highly unlikely to have a beneficial effect on Alzheimer's patients (see Larry's article link).  

The removal of nearly all amyloid has no effect on non-ApoE4 carriers and only a modest effect on ApoE4 carriers.  Moreover, many people have a substantial amount of amyloid in their brain without having Alzheimer's disease.  So even if misfolded filamin A is enhancing the toxic effects of amyloid, it is improbable that restoring filamin A to its original state is going to make much difference.

Simufilam like Aricept (donepezil) contains a ketone group and like Aricept and Anavex's blarcamesine may be a sigma-1 receptor agonist both of which reduce oxidative stress, but unlike Anavex's blarcamesine simufilam does not appear to be a direct peroxynitrite scavenger.  Blarcamesine produces better results at one year than either simufilam or Aricept.