Wednesday, January 18, 2023 1:57:28 PM
Yes, the margin of error factor plays big in trials with low n, low participant numbers. Can the reduced fall factor be a valid conclusion in the trial with only 161 and 301 patients in the two arms? Actually, an understanding of the unique mechanisms of action (MOAs) of blarcamesine thoroughly validate the reduced fall rate datum. Here’s why.
It is now well understood that blarcamesine binds to, is a sigma-1 receptor protein ligand. With this chemical attachment the sigma-1 protein’s activities are changed or enhanced. It is activated, whereby, among other things, calcium ion transport is favorably modulated, chromatin surrounding genes in chromosomes is unwound, and proteins (enzymes in particular) are properly folded. All of that facilitates and normalizes a multitude of downstream cell processes in neurons. With that, neuron functions are restored. And one of those functions would be neurotransmitter modulation of the motor neurons controlling the muscles that prevent falls.
Additionally, blarcamesine has been proven to restore normalized levels of GABA, gamma-aminobutyric acid in GABA-deficient neurons. With this neurotransmitter at normal levels, the muscles involved in falling can operate more normally.
So, no, blarcamesine’s ability to reduce falls in people suffering from Alzheimer’s is not a guess in some clinical darkness, requiring deep statistics from a thousand or more patients. Blarcamesine’s now-understood chemistry operated very well in 301 Alzheimer’s patients. Mark me on this. Should a larger, n = 1000 trial be conducted, the discovered fall rate reduction will be closely the same. Blarcamesine's same restorative chemistry will be in operation. It won’t change when greater numbers of participants are added to a new trial (should there be one).
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