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polarbear77

10/30/17 3:34 PM

#127399 RE: F1ash #127394

Thanks Flash and if you are having a hell of a time finding past AD studies with individual participants improving and stabilizing similar to our Anavex trial through 57 weeks (particularly on a blood concentration dependent basis), then I’m not sure how you think I’ll be able to beat your research skills.

And not to be glib, but if Dr George Perry had this to say (a year ago):

[George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, commented, “Although this is an open label study with 32 patients, I have never seen mild-to-moderate Alzheimer’s patients maintain near baseline cognitive and activities of daily living function and positive correlation with all other measures over a 41-week trial period in any prior study with an approved or experimental drug. It is quite plausible that complex CNS diseases like Alzheimer’s may require a comprehensive approach, including restoration of cellular homeostasis.”]

Then shouldn’t a non-scientific mind, such as myself, be able to take more stock in his research/experience than any google search of my own?

I’d welcome any poster to provide examples of Anavex-level percentages of improvement/stabilization (either 7 of 25 or 5 of 9) over 57 weeks.

I’ve simply never before seen such examples. Ready to learn however.

GLTAL

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blu_1

10/30/17 5:20 PM

#127427 RE: F1ash #127394

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 only. 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. And remember, this Ph 2A trial used non-optimized dosing! The first 5 weeks of the trial were different the following 52 weeks. Those first 5 weeks including IV administration of 2-73 at only 3 or 5mg and a 12 day washout period after the first 12 days of the trial. 7 patients were not on donepezil. Those that were on donepezil, were probably on it for more than a year, so how effective the donepezil was at that point is anyone's guess.

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 and blood concentration dependent.

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