Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease.

Since the primary endpoints in both trials did not reach statistical significance, all other p-values <0.05 for both predefined subgroups and post hoc analyses are considered nominally significant and hypothesis-generating.

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3.1.5 Biomarker sub-studies There were no significant differences between simufilam and placebo for changes from baseline to Week 52 or Week 76 on tertiary endpoints of sub-studies for plasma biomarkers in either trial ( n = 27–47 per group; Table 2 ), although there was a favorable trend on plasma GFAP, a neuroinflammation marker, in the 100 mg group in REFOCUS ( p = 0.07).

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