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Wednesday, March 16, 2022 11:26:02 AM
Yes, the four data plots show very significant score improvements for the 14 weeks of the trial. Those, alone, when confirmed in the Phase 3 study, will prompt FDA approval of blarcamesine for Parkinson's disease dementia.
But two related considerations. First, the trial ran for only 14 weeks. But the therapeutic dose (50mg) was not attained until it was titrated up to that level, starting in third week. Simply, the targeted 50mg dose level occurred only for the final 11 weeks. But even in that shorter period, the favorable therapeutic scores were dramatically increased.
However, secondly, what evidence is there that this 14/11-week dosing period is optimal? In the trailing weeks were the score increases tapering or leveling? Or, had the trial continued for another three months or more, would the scores have continued to improve?
Favorably changing neuron physiology takes time. In this trial, 14 weeks were allocated, with incontrovertible success. But in chronic dosings, over much longer periods, months, even years, there is the prospect that healing (sorry, had to use that term; it applies) might continue; all the way to normalcy.
Four questions for blarcamesine:
1. Can it slow the progression of various CNS diseases?
2. Can it stop the progression of various CNS diseases?
3. Can it reverse progression of various CNS diseases?
4. Can it prevent the onset of various CNS diseases?
In this study blarcamesine not only slowed or stopped the progression of Parkinson's disease dementia (PDD), it reversed it. People taking the drug got better.
It stands to reason, therefore, that were there an early, pre-symptomatic detector of PDD vulnerability, blarcamesine dosings could be prophylactic, preventing the onset of the disease altogether.
What, then, are the probabilities or possibilities of similar effects of blarcamesine in Alzheimer's disease? Will it be shown to not only slow or stop Alzheimer's progression, but, in fact, reverse it? Even better, will it actually prevent the disease?
Very likely, on all accounts. Let the trials begin.
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