The definition of a placebo is the following: "a substance that has no therapeutic effect, used as a control in testing new drugs."
The Anavex Alzheimer's Phase 2b/3 trial is designed to compare the response of: the 50 mg per day cohort to the placebo cohort the 30 mg per day cohort to the placebo cohort
Again: The definition of a placebo is the following: "a substance that has no therapeutic effect, used as a control in testing new drugs."
It is early Alzheimers The progression of the disease varies greatly at the early stage. It is very possible that some patients will not have deteriorated after 48 months..
In the placebo arm whatever that number is.. simply deduct that number from the responders in the 30mg cohort and the 50mg cohort..
So if 5 out of 170 placebo consort are. Close to baseline..
And 85 from the 30 Mg cohort are at baseline or above.. reduce that number to 80..
And when 170 of theb50 Mg are at baseline of above you reduce that to 165..
Making the number 245 out of 330 are at or above baseline due to Blarcamesine..
Why argue minutiae? The meat of the data will leave zero doubt only adulation and joy and will make these arguments pointless for the shorts.
those are drugs many anavex trial patients WILL be on for at least 3 months in this trial and WILL be in the placebo group.
That's quite possible. And the reason 90 days minimum was selected as a criterion is because it's evident that any small benefit from donepezil diminishes after a 6-12 weeks... thus, ultimately similar to placebo (i.e. nothing).
They will be able to see that donepezil + blarcamesine, as well as blarcamesine alone, perform better than donepezil alone.