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TrueTrades

08/12/15 4:43 PM

#13536 RE: mixedup #13533

Yes, I just kind-of thought that, too. If they haven't completed enrollment for P2a, then we couldn't get full data for 32 PART A patients by Sept.

That would mean if we hear of enrollment complete, the PART A 36-day countdown starts.

I think somehow it's a little farther along than that would suggest, but I like to be conservative. Perhaps it's only 2 - 5 of the 32 not yet enrolled and they will present full data on 25 out of 32, like the 12 out of 32 preliminary? It is adaptive.

The enrolees must go through a battery of tests, questions, scoring, etc...and there are personal expenses, not covered, as well as the extra stress put on the patient. I view long enrollment phases as a sign of rigorous selection.

bigstocksnbonds: Thank you. Every good circus needs ringmasters! ;-)
§AVXL
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nob118

08/12/15 5:09 PM

#13544 RE: mixedup #13533

Why it would be hard to enroll people in the study -
Anyone involved with alzheimers diagnosis learns quickly every second of every day counts. Once you lose ground in anything, it is lost. There is nothing out there YET that permits the brain to recover. Delaying treatment, I feel comfortable in saying, is NEVER given as an option.

So, knowing that and knowing there is already medication on the market that has been proven to medically slow the progress of the disease even if it is minimal, it would be a life changing decision that these people are making to forego the proven and 'try their luck' with the experimental.

These people were risking 182 days and now 364 days of their lives on a medication that may or may not work. If it does not work, their bodies do not magically reverse back to what it was before they started in the trial. Those that participate in this or any other trials are real heroes for the benefit to the rest of us. I, as so many others, am hopeful they all come out on the winning side.

I'll make it even easier to understand - I have a 'magic' pill that will make you live forever or kill you right now. It's a 50/50 shot. Would you take it?

Great day today $$$. This is a very exciting time in all respects.

GLTU
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JB3729

08/12/15 6:05 PM

#13555 RE: mixedup #13533

I wonder why it takes so long just to enroll 32 people.


This is an adaptive trial. A few patients are treated and then the dosage is changed for the next group as a lot of combinations are tested. It's like running many trials in the same trial.

Most participants are still on donepezil during the trial. They aren't giving anything up to be in the trial.
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JPG77

08/12/15 6:46 PM

#13565 RE: mixedup #13533

"I wonder why it takes so long just to enroll 32 people"

I suspect recruitment was fairly slow at the beginning because, until July 22nd, they didn't know how people would respond to the treatment. Now that it's widely known, I think recruiting will speed up, although I suspect they've already filled the remaining slots by now.