The P2-A trial that began in 2014 was designed for safety, mtd and signs of efficacy from what I understand. They weren’t using precision medicine to select the patients, they were finding people with mild to moderate Alzheimer’s by the best methods available at the time. This was akin to the old style recruitment for an Alzheimer’s study.
Out of that somewhat random, compared to the new precision medicine, selection of applicants we got 6 super responders who changed the way we think of Alzheimer’s treatments. I say that because the Editor in Chief of the Alzheimer’s Journal, George Perry acknowledged as much. The others in the 32 person study have had varying results, not pushed forward into the light for us to examine as much. A lot of people are, I think, overly concerned about the others that may be doing pretty well. We don’t know for sure. 7 dropped out for reasons unknown but not related to the drug so we’re down to 25, still with 6 resuming daily activities. All 25 and their caregivers emphatically requesting to remain on A2-73. They feel better, they feel safe and they are happier than anyone could have imagined 3 years ago.
The overseer of the study, Professor Stephen Macfarlane, has clearly pointed out that this study was not powered to show efficacy and the great results were unexpected. Yet we have changed the way Alzheimers treatments are now looked at. Anavex has raised the bar.
Now after 2 years of results and advances in examining and understanding how 2-73 works, the selection process for the 2b/3 is about to begin. The FDA has re-written the rules for how the study will be run, I think with Anavex in mind, as it will be the first Alzheimer’s study to be conducted under the 21st Century Cures Act.
I hope and believe they have a good idea why the 6 SR’s improved the way they did and the new trial patients will have more in common with them than with the other 26 that began the P2/A. Plus the dosing regimen will be optimized for those that we already know respond very well to 2-73.
Sometime in the next 46 days history will be made and an Alzheimer’s disease trial study will have the best chance of success we’ve ever seen.
imo
I believe the data. I believe the Real World Results and Caregiver input. I believe the 25 patients that have been on 2-73 for almost 3 years and want to stay on it.
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