Replies to post #71405 on Anavex Life Sciences Corp (AVXL)

[Diamondhands45]

Donezepil will be placebo arm

[eagle8]

Isn't it so that the Donepizal arm is already the SOC ?

So no need for a D.-arm.

GLTU

[georgejjl]

Android,

I agree.

Given the results at 31 weeks, then the Phase 2/3 trial should be Anavex 2-73 compared to donepezil. It should still be possible to perform a double blinded study as long as both Anavex 2-73 and donepezil are given in identical form and size capsules. That way neither the patient nor the doctor knows if the patient is given Anavex 2-72 or donepezil only the independent trial administrator knows and is correlating the results with the treatment.

See the following regarding active control group trials:

Active-Control Equivalence Trials (Noninferiority Trials)
The ability to conduct a placebo-controlled trial ethically in a given situation does not necessarily mean that placebo-controlled trials should be carried out when effective therapy exists. Patients and physicians might still prefer a trial in which every participant is given an active treatment. What remains to be examined is why placebo-controlled trials (or, more generally, trials intended to show an advantage of one treatment over another) are frequently needed to demonstrate the effectiveness of new treatments and often cannot be replaced by active-control trials showing that a new drug is equivalent or noninferior to a known effective agent. The limitations of active-control equivalence trials (ACETs) that are intended to show the effectiveness of a new drug have long been recognized and are well described (15–33) but are perhaps not as widely appreciated as they should be. A recent proposed international guideline on choice of control group addresses this issue in detail (33).

http://annals.org/article.aspx?articleid=713868

Good luck and GOD bless,

George

[JUST 10-11-12]

you know I am not sure why we have to compare anything to Aricept..the drug is useless...my doctor does not even subscribe this to elderly people

[JUST 10-11-12]

a no brainer

[shortridge3w]

That is absolutely correct. As I compared the data of TauRx p3 and 2-73 p2, the statistic value is similar though p2 do not have placebo arm.