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Re: Doc328 post# 387865

Friday, 12/02/2022 12:49:39 PM

Friday, December 02, 2022 12:49:39 PM

Post# of 517508
Yep that is exactly what they did. One mystery solved. Now show us the ITT data

From initial presentation slide 21:
footnote says

a
Analysis method: logistic regression
ITT: Intent-to-treat



and in revised deck:

Ref.: Reference
a
Analysis method: t-test on change from baseline at the end of treatment (week 48) on subjects with available scores at week 48.
Mean change from baseline obtained from an average of ADAS-Cog score change for each subject.
Mean of change from baseline not equivalent to subtracting mean baseline scores from mean end of treatment scores when all subjects do not have both measures.
bRelative Reduction in Decline = (1- [mean change in active/mean change in placebo])*100



This is not the standard ITT population . It is the protocol completers.

Likewise slide 22 old slide:

Ref.: Reference
a
Analysis method: t-test on change from baseline at the end of treatment (week 48)



New slide:

Ref.: Reference
a
Analysis method: t-test on change from baseline at the end of treatment (week 48) on subjects with available scores at week 48.
Mean change from baseline obtained from an average of CDR-SB score change for each subject.
Mean of change from baseline not equivalent to subtracting mean baseline scores from mean end of treatment scores when all subjects do not have both measures.
bRelative Reduction in Decline = (1- [mean change in active/mean change in placebo])*100



They also added this to slide 25

a Maintenance phase of trial

What about the poor patients who could not tolerate the drug during titration?? Does their safety data not count?
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