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Re: TrueTrades post# 20179

Monday, 10/05/2015 2:13:10 AM

Monday, October 05, 2015 2:13:10 AM

Post# of 461851
Good catch, ipulator_man, I do stand corrected regarding ADAS-Cog, which is not the same as CBB (Cogstate Brief Battery). I was focused more on MMSE since the Nov. 7 emphasis is there, and too hastily assumed that "Cogstate" in the July 22nd PR referred to ADAS-Cog. Note, though, that Cogstate does not refer to ERP--the CBB test is distinct from that one.

Good catch as well on the Cogstate data being collected not only in Part B, but Part A as well.

My point holds regarding MMSE, though. That data is only collected in Part B (with comparison to baseline first possible at week 12), so the July 22nd PR had to be referring to Part B data when it asserted that MMSE scores were "consistent with the observed trend" in P300 numbers.

I am not saying Anavex released any exact MMSE numbers on July 22nd -- it didn't. However, since we already know from published data over the last two decades that at 12 weeks donepezil induces on average about a one-point improvement in MMSE score from baseline, we can extrapolate from Anavex's assertion -- that early MMSE data in the trial (which could only come from Part B individual patient data collection at 12 weeks) is "consistent with the observed trend" in P300 of a 4x improvement over donepezil alone -- that patients in the trial who had reached the 12th week of Part B by July 22nd were showing roughly a four-point improvement in MMSE from baseline on average. So while Anavex did not give a figure for MMSE improvement (probably because the sample size was just a handful of patients at that from), their language allows us to conclude confidently that the MMSE scores they did have at that point were in the range of roughly a 3-5 point improvement in MMSE. Anything lower or higher than that is hardly "consistent with the observed trend" of a 4x improvement over the effect of donepezil alone.

The question now of course is whether subsequent patients reaching week 12 of Part B (and by Nov 7 there should be at least 12) will solidify MMSE results from the earliest enrollees in the trial.

My intention is not to correct you -- I enjoy and benefit from your posts -- but to share DD and arrive at the best collective knowledge that we can muster. I'm grateful to you for catching my mistake regarding ADAS-Cog!
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