Four billion years of evolution is against my judgment so don’t trade on this.
Synthetic Placebo Arm and Statistically Significant…
Alzheimer’s Disease Neuroimaging Initiative ADNI also was given data on placebo arms by a number of companies in the industry. This data can be used to create a model of a statistically significant synthetic (virtual) placebo arm. The recruitment of patients can be limited to only those in the dosing arms since the placebo effect working in one trial is identical to workings in another. Namely, the placebo bias is identical from trial to trial. Many Alzheimer’s trials involve hundreds if not thousands of subjects so doing away with the onerous and expensive placebo arm might be a great help to many companies.
We might not believe it initially but the placebo effect has been even traced to genetic markers. I have checked myself for it and I am a highly susceptible person to the placebo effect. I have to confess that it is true that I always feel better after seeing a physician or getting any medical help, or even expecting it.
If you want to see your genetics material in terms of trait relevant to health, personality, intelligence and physical abilities you can transfer the DNA results from one of those ancestry sites to Genomelink . These markers have varying degrees of reliability but sure it is fun.
Of course, the final thing here is the selection of those patients whose genetic make up allows them to be responders. This is certainly in the scope of ADNI activities.
I hoped that Dr. Missling would also use this opportunity to present data on the plaque deposits changes in the brains of the responders. I don’t think or remember that such data had been collected at the beginning of the phase2a. It would be very helpful as FDA considers, it might have changed since that amyloid deposits are the only valid biomarker of the disease. Proving that these deposits were reversed in those who responded versus those who did not is from the standpoint of the regulatory body hard evidence of undeniable progress. I would appreciate it if anybody would remember this hence my memory barely serves me. Please, leave a response to the post.
Another aspect of this is that statistical significance is related to the background noise. I am here revoking the image of statistics as looking for a signal in background noise. It is like making out a word in a very loud night club. LOL. Similarly, I can compare the placebo arm in Alzheimer’s to very low-level noise as the outcome for patients leads to quick deterioration in a very predictable way. Any word spoken over this din can be clearly discerned. This nature of Alzheimer’s progression moves the bar low on validating trials with even small samples of patients who respond to medication aa statistically significant study.
I have a dog in this hunt, not only financial but my reputation if it ever existed. I went on the limb many times making wild guesses about the Anavex 2-73 and $AVXL. Some were grossly wrong, but now I face the ultimate moment as data on Blarcamasine is to be validated (hopefully) and the extent to which the drug is to help the patients can be at least given initial numbers.
So without much ado.
That is the composition of the population of High Concentration Cohort when corrected selection for SIGMAR1 and COMT genotype will look like. You can judge me upon how well this model fits the upcoming data from the LB20 presentation at CTAD 2019.
$1.00 is about one bottle so .....please contribute..