They are using the MMSE, a standard but often crit
Post# of 1460
Posted On: 10/29/2015 9:28:46 AM
They are using the MMSE, a standard but often criticized test of cognition, but they are also using some new tests from AMBS. The MMSE is the current comparator -- whether blood test results will be accepted, understood, and ultimately prove to be valid, who knows.
Here's the MMSE -- you can see that this is only going to work for people who are already in an advanced stage:
http://www.heartinstitutehd.com/Misc/Forms/MM...128605.pdf
They initially titled their Nov. 7 talk with a flat out "improves cognition" in the title but then when the official program came out, the title had been changed. There have been several theories as to why for the change, but the one that seems probable is that this is one of the conferences that doesn't want any press release until the day of the presentation.
There is no placebo arm, they're using improvement in patients as their endpoint. Control arms in Alzheimer's require huge groups of patients because the disease progresses in such an individual fashion. The old saying is, "When you've seen one case of Alzheimer's, you've seen.... one case of Alzheimer's." In other words, every case is unique.
This is a small study -- only 20 additional patients. The Phase 1 trial was only 12 patients, but 10 of the 12 showed improvement anecdotally and those people lobbied to be allowed to continue taking the drug (which they are doing). This also is being done in Australia. I am not sure how that will affect approval in the U.S.
Here's the MMSE -- you can see that this is only going to work for people who are already in an advanced stage:
http://www.heartinstitutehd.com/Misc/Forms/MM...128605.pdf
They initially titled their Nov. 7 talk with a flat out "improves cognition" in the title but then when the official program came out, the title had been changed. There have been several theories as to why for the change, but the one that seems probable is that this is one of the conferences that doesn't want any press release until the day of the presentation.
There is no placebo arm, they're using improvement in patients as their endpoint. Control arms in Alzheimer's require huge groups of patients because the disease progresses in such an individual fashion. The old saying is, "When you've seen one case of Alzheimer's, you've seen.... one case of Alzheimer's." In other words, every case is unique.
This is a small study -- only 20 additional patients. The Phase 1 trial was only 12 patients, but 10 of the 12 showed improvement anecdotally and those people lobbied to be allowed to continue taking the drug (which they are doing). This also is being done in Australia. I am not sure how that will affect approval in the U.S.
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