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runncoach

06/04/19 4:48 PM

#11150 RE: Whatsupp #11147

It was already stratified as it was last time. Memantine was stratified into the same ranges as well.
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runncoach

06/04/19 5:01 PM

#11154 RE: Whatsupp #11147

It's on page 7 of the protocols.
https://clinicaltrials.gov/ProvidedDocs/68/NCT02431468/Prot_000.pdf

The "N" would have been incredibly small in the non memantine population and then breaking that down into the 2 stratified groups would have made it a bit hard to tell. Maybe we can see a trend in either direction this time. One thing I can tell you though is this issue has been something I have pushed very hard on and the company clearly states that thus far in the CU patients and in the overall numbers or subgroups from the last trial that they have seen no reason to think the drug shows more improvement in someone with a score of 4 than if they had a 15 or vice versa. I also ran the numbers with the memantine average SIB scores verses ours and asked about the half dozen point difference and they said looking at it that way as well there is still no reason to think someone with a 70 on the SIB would be any more or less likely to show greater improvement than someone with a 50 or an 80. Maybe that changes with the bigger numbers this time, but just as with APOE3/4 issues or just as with 94% improvement, the company feels that degree of impairment or reason for the disease(at least thus far in the moderate to severe patients) does not impact the nearly universal improvements. That's my opinion based on my DD on what we have seen so far anyway.