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F1ash

10/30/17 5:42 PM

#127433 RE: blu_1 #127427

Something you're not accounting for is the Anavex trial is for Mild to Moderate AD patients. They decline much faster than just Mild AD patients. Make sure you're comparing the Anavex trial with other trials that include Mild to Moderate patients. And also make sure the mean ages of the two groups you're comparing are the same as that also has big effect on rate of decline.

MMSE is subject to variability. Anavex also used Cogstate, ERP's and P3a amplitude using the trademark Cognision system, Ham D, and ADCS ADL assessments. Changes in scores for all assessments were consistent with each other over time and were also dose/blood concentration dependent.

To assess cognition in the Ph 2/3, Anavex will be using ADAS Cog



My second source was not MMSE specific. I’d love to hear your breakdown of it’ validity in comparison to Anavex’s trial.

https://alzres.biomedcentral.com/articles/10.1186/alzrt210#Tab2


Something else I would like your opinion on:

“The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. On average, the MMSE score of a person with Alzheimer's declines about two to four points each year.”

https://www.google.com/search?ei=Wpn3WfiqM4q9jwS0sbHwAg&sjs=3&q=mmse+alzheimer%27s+diagnosis&oq=mmse+alzheimer%27s+diagn&gs_l=mobile-gws-serp.1.0.0i22i30k1.30409.33981.0.35057.7.7.0.0.0.0.474.1707.0j1j4j0j1.6.0....0...1.1.64.mobile-gws-serp..1.6.1706...0.224.FSPT8cTtanw

But here was the criteria Anavex used

“Diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria.

A brain CT or MRI scan performed within last 12 months from day of screening consistent with the clinical diagnosis of probable AD.

Age from 55 to 85 years inclusive.
MMSE score of 16-28 inclusive.



https://clinicaltrials.gov/ct2/show/NCT02244541?term=Anavex&rank=1

Did they have any patients that had a score of 25 to 28? They apparently wouldn’t even qualify as “mild” if I’m reading correctly.