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Sunday, October 23, 2022 3:31:31 PM
I can see why one would think that, but it just isn’t how it works.
The good news is that in a randomised controlled trial the allowed co-administered drug as well as the placebo will be operable pretty much with even weight across all arms eg. placebo, mid and high dose.
So if the drug being tested, A2-73 in this case, really works it should distance itself from placebo assuming it is superior to the co-administered drug eg. Donepezil.
At this point Anavex can be fairly certain that Donepezil is not interfering much with the MoA of A2-73 because that had been examined and then confirmed also in the P2 PDD trial where some patients would also have been on Donepezil.
From clinicaltrials.gov P2 and OLE trials:
“Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study.”
The good news is that in a randomised controlled trial the allowed co-administered drug as well as the placebo will be operable pretty much with even weight across all arms eg. placebo, mid and high dose.
So if the drug being tested, A2-73 in this case, really works it should distance itself from placebo assuming it is superior to the co-administered drug eg. Donepezil.
At this point Anavex can be fairly certain that Donepezil is not interfering much with the MoA of A2-73 because that had been examined and then confirmed also in the P2 PDD trial where some patients would also have been on Donepezil.
From clinicaltrials.gov P2 and OLE trials:
“Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study.”
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