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NWDR

04/25/16 1:47 AM

#60279 RE: McMagyar #60263

I definitely agree that it seems having a control group get something you know is only go to slow down (at best) Alzheimer's for a small length of time seems unethical.

However, the regulatory agencies may still require a control arm in a PH3 trial for it to be considered sufficient for drug approval.

What might happen, conjecture on my part, is that the PH3 trial design is such that it allows a crossover from patients in the control group who progress a certain amount to the arm of the trial getting A2-73.

Perhaps something like a measurement of MMSE at baseline and then when a measured reduction (so many points) occurs then the patient can cross over and start receiving A2-73.

I would rather just give 100 patients with mild to moderate AZ and see how they do for 6 months. But the regulatory agencies might insist on the control arm. If they do, then the cross over may help with the ethical concerns.

If the complete data set is even one quarter as good as the glimpses we are seeing then I would expect the PH3 trial to be stopped some 6 months after it has enrolled a significant number of patients. It will not take very long for the treatment group to show an overwhelming advantage in function vs. the control group.

Cheers.


frrol

04/25/16 8:28 AM

#60321 RE: McMagyar #60263

A placebo isn't the same thing as a control, which is what you're talking about now.