Replies to post #91001 on Anavex Life Sciences Corp (AVXL)

[kld2]

problem is, you don't know why they responded. (I have been reading this board long enough to see the confusion on why there was a surge, and no one, yet, has offered a factual reason.) Not saying it isn't real, but it could just as easily be unreal. I think it has been pointed out that even after 3 years MMSE scores on patients can improvement.

[F1ash]

Studies and distilled clinical experience suggest:

"approximately 25% of patients taking cholinesterase inhibitors can be classified as ‘non-responders,’ experiencing clinical decline at the pre-treatment rate;

• approximately 25% of patients may be termed ‘super-responders’ with a significant and sustained improvement in function and cognition;

• the remaining patients may be expected to have modest improvement, or to be maintained at the same level without decline, over the first year of treatment.2,4"

http://www.stacommunications.com/journals/cme/2004/August/pdf/051.pdf


Unfortunately the time frame (a year?) is not specified.



Cholinesterase inhibitors do not often have a significant impact on cognitive tests, such as the Mini Mental Status Exam (MMSE). However, benefits may be seen in global ratings by patients or caregivers, improvements in activities of daily living (ADLs), or instrumental activities of daily living (IADLs), and reduction in behavioural disturbances due to the dementia.

So that last "bold" makes the whole thing clear as mud.

[F1ash]

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Show me any large scale AD study from the past where they had even 1 super responder 57 weeks into the trial. You can't.
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1999 is from the past.

"For patients with only 1 year of follow-up, MMSE score changes ranged from a decline of 23 points to an improvement of 7 points. As follow-up interval increased, the range of score changes narrowed, but even after 4 years, 13 (15.8%) of the 82 patients returning had no meaningful decline."

http://jamanetwork.com/journals/jamaneurology/fullarticle/775209

A blowup of Figure 4 ( Graphical representation)

http://jamanetwork.com/data/Journals/NEUR/6482/noc8161f4.png

Note that several scores were even improved (~+3) even after 2 years.

More DD......

"The dropout rate should be compared between the different study arms. Design aspects, including randomization and blinding, should be checked for signs of bias.

"The blinding process is defined as single-blind if the subject is unaware of the allocation, while doubleblind refers to a study in which the investigators are also unaware of the individual patient’s allocation. Blinding of both participants and evaluators is equally important, as patients who are aware of their intervention may have lower compliance, and investigators who are aware of the intervention may overestimate a treatment effect. Not surprisingly, studies comparing outcomes with and without blinding have shown a significant overestimation of the treatment effect in studies conducted without blinding.


"Another consideration with graphs is that, while plots of means without an indication of variability may be more aesthetically pleasing, these figures do not give the reader an understanding of the variation in the data. Ideally, this variability should be presented by plotting all the data points or, if the data are summarized, by showing means with 95% confidence interval bars instead of standard error or standard deviation bars."




https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380258/


I was indeed hoping you were correct by the way.