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Re: Hosai post# 478617

Friday, 01/03/2025 1:02:22 PM

Friday, January 03, 2025 1:02:22 PM

Post# of 518957
It would seem likely the co-variate 'baseline MMSE status' does not merely refer to whether the participants baseline MMSE was above or below 20. I would imagine it was a grouping such as Mild cognitive impairment (20-24) and Mild to moderate (25-28) or some other type of grouping. Meaning there would indeed have been adjustments for any disparities at MMSE baseline starts between dosed/placebo which are reflected in the main final results we are given.

Obv completely continuous rather than categorical would have been the most relevant however they are already adjusting for other co-variates such as site visit centre (which regulators tend to insist on I believe) and too much co-variant analysis can become problematic.

I don't think it can have merely meant above or below 20 when so few patients were below 20 (making such an analysis fairly pointless) and the eligibility criteria for the trial itself said only patients above 20 MMSE -

"A Mini-Mental state examination (MMSE) score of 20 to 28 at the screening and randomization visits [27]"

Obv it's therefore a slight quirk that it had patients below 20 MMSE but I imagine there was just a few who were on the cusp at the initial screening & randomization visit.
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