Actually I think it pretty smart of Anavex, whether by design or dumb luck due to lack of funding.
This is primarily a dose finding trial, with secondary evaluation to see if EEG/ERP P300 correlates to Mini Mental State Examination (MMSE) and Cogstate tests. 32 patients receive the drug (in essence larger than the first part of the IMAGINE trial) divided between 16 men and 16 women. This trial was never designed to be a pivotal trial, but the open label adaptive design allows them to change various parameters in an attempt to identify the best targets for their drug. See FDA draft guidance on adaptive trial design.
In hindsight, had Prana also done something similar and put all 42 patients on the drug, the share price would be much higher I believe. Really what was the 15 person placebo going to prove? So far it proved that disease progression is not linear ...
I do have higher hopes for the final IMAGINE extension results because all patients are on the drug and results are just being measured against baseline. Almost the same thing Anavex is doing with their overall trial.
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Actually I think it pretty smart of Anavex, whether by design or...
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