ABCLEAR2 population of 336 participants and ABCLEAR3 of 222 participants. In both the ABCLEAR2 and ABCLEAR3 populations, the co-primary outcomes as well as all other clinical outcomes were statistically significant. ABCLEAR3 blarcamesine group vs. placebo at Week 48 (ADAS-Cog13 difference of -4.179 [95% CI -6.512, -1.845]; P=0.0005; ADCS-ADL difference of +3.131 [95%CI 0.720, 5.542]; P=0.0111; CDR-SB difference of -1.076 [95% CI -1.645, -0.508]; P=0.0002; QoL-AD Patient improvement from baseline of 0.334 [95% CI -1.164, 1.833] and difference of 1.848 [95% CI 0.455, 3.241]; P=0.0095). The clinical outcomes were strongest in the blarcamesine 30 mg cohort (ADAS-Cog13 difference of -4.739 [95% CI -7.370, -2.108]; P=0.0004; ADCS-ADL difference of +4.245 [95%CI 1.518, 6.972]; P=0.0024; CDR-SB difference of -1.414 [95% CI -2.054, -0.775]; P<0.0001; QoL-AD Patient improvement from baseline of 0.182 [95% CI -1.472, 1.835]; and difference of 1.651 [95% CI 0.455, 3.241]; P=0.0392). Whole brain volume loss in blarcamesine group vs. placebo was significantly further decreased from ITT population (37.6%, P=0.0019) to ABCLEAR3 population (44.5%, P=0.0019). Participants in the 30 mg group ABCLEAR3 full safety population with ≥1 serious treatment-emergent adverse events (TEAEs) occurred in 10 participants (12.7%) in the blarcamesine and 6 (9.1%) in the placebo group. Common TEAEs included dizziness, which was transient and mostly mild to moderate in severity. There were no deaths in the blarcamesine group and 1 in the placebo group.
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