"MoCA score change from preliminary blinded data shows a standard deviation of 3.2 points and a sample size of 54 subjects per arm to provide a 90% power to detect a mean betweengroup difference of 2 points at p<0.05."
I highlighted the word change here because the company seems to be suggesting that there are two seperate groups. One that is improving, the other is not. Given that patients following stroke / heart attack with hypertension see an average decline of 1 point in MoCA per year, any improvement would be significant especially across the entire patient group. If the company added both the responders and the non responders and saw even a small decline or lack there of that would be significant.
How are the subjects divided into each arm if the data is blinded? Is it a responder group vs. a non responder group? It would be pretty significant if the company can already see a positive response in the blinded data. Patients with hypertension at this age and following a heart attack of stroke see a rapid decline in their MoCA scores.
Thanks,
Pomp