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Thursday, 11/05/2015 8:08:10 PM

Thursday, November 05, 2015 8:08:10 PM

Post# of 463832
From the CTAD Abstract: In the secondary outcome endpoints preliminary analysis of data from subjects shows an average improvement of the MMSE score at week 5.

From ClinicalTrials.Gov: Mini-mental state examination score (MMSE) [Time Frame: Baseline, and during the extension period at Week 1, 12, 26, 38 and 52]

Difference: The CTAD abstract clearly indicates MMSE shows an average improvement at week 5. Is this evidence of a change in the adaptive trial design? Perhaps instead this means that, on average, improvement of MMSE scores occurred between Week 1 and Week 12, at Week 5 during the extension period? In other words, after dosage optimization in Phase IIA Part A, MMSE improved, on average, earlier than anticipated.
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