Wednesday, July 08, 2020 8:25:53 PM
https://clinicaltrials.gov/ct2/show/results/NCT03560245
First of note is that the more moderate of the severe patients MMSE 10-14, represented nearly 2/3 of the patients (34) luckily for us. They were scored in 4 cohorts at weeks 5,9,13, and 15. 18 patients in the more severe group MMSE 4-10 were scored at the same intervals.
Of the more severe patients, scores decreased at 3 of the 4 intervals. Of the 34 patients in the more moderate stratum ALL 4 intervals showed an increase in scoring. Also of note is that ALL 4 of those groups outscored the placebo at those same intervals, even though placebo did fairly well.
Also of note is that 29 patients showed a positive scoring slope out of the combined patient number of the 52 patients. Based on the rest of the data it is likely that all 29 (perhaps 1 or 2 were in the other group) came from the 34 more moderate patients. In other words over 80% of patients in the moderately severe group improved test scores. Yes placebo patients did as well but scores on average were less at ALL 4 of those intervals. This is likely why the NIH gave us the grant. Just my quick take.
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