Table 5.
Efficacy by visit and genotype in the ITT w/LOCF population*
| Group; N | AC-1202 | Placebo | Difference (95% CI) | p-value |
| Day 45 Mean Change From Baseline | ||||
| ADAS-Cog; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | -0.177 | 1.730 | 1.91(0.26, 3.55) | 0.0235 |
| APOE4(-); 29AC, 26PL | -1.724 | 3.050 | 4.77(2.13, 7.41) | 0.0005 |
| APOE4(+); 38AC, 31PL | 0.904 | 0.957 | 0.05(-2.31, 2.42) | 0.9644 |
| MMSE; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | 0.013 | -0.238 | -0.25(-1.12, 0.62) | 0.5693 |
| APOE4(-); 29AC, 26PL | -0.276 | 0.038 | 0.31(-1.05, 1.68) | 0.6496 |
| APOE4(+); 38AC, 31PL | -0.105 | -0.645 | -0.54(-1.76, 0.68) | 0.3844 |
| CGIC†; ITT w/LOCF | ||||
| ITT; 61AC, 58PL | 4.21 | 4.43 | 0.22(-0.25, 0.68) | 0.3536 |
| APOE4(-); 23AC, 24PL | 4.22 | 5.04 | 0.82(0.11, 1.54) | 0.0240 |
| APOE4(+); 30AC, 28PL | 4.27 | 3.79 | -0.48(-1.12, 0.16) | 0.1407 |
| ADAS-Cog; randomized only w/LOCF | ||||
| ITT; 61AC, 62PL | 0.000 | 1.725 | 1.73(-0.04, 3.49) | 0.0548 |
| APOE4(-); 24AC, 26PL | -1.514 | 3.050 | 4.56(1.84, 7.29) | 0.0012 |
| APOE4(+); 31AC, 30PL | 1.054 | 0.922 | 0.13(-2.34, 2.60) | 0.9161 |
| Day 90 Mean Change From Baseline | ||||
| ADAS-Cog; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | -0.312 | 1.227 | 1.54(-0.17, 3.24) | 0.0767 |
| APOE4(-); 29AC, 26PL | -1.747 | 1.614 | 3.36(0.67, 6.05) | 0.0148 |
| APOE4(+); 38AC, 31PL | 0.868 | 0.989 | 0.12(-2.29, 2.53) | 0.9211 |
| MMSE; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | -0.206 | -0.299 | 0.09(-0.81, 0.99) | 0.8397 |
| APOE4(-); 29AC, 26PL | -0.276 | 0.385 | 0.66(-0.80, 2.12) | 0.3710 |
| APOE4(+); 38AC, 31PL | -0.474 | -0.710 | -0.24(-1.54, 1.07) | 0.7209 |
| CGIC†; ITT w/LOCF | ||||
| ITT; 64AC, 60PL | 4.41 | 4.62 | 0.21(-0.29, 0.71) | 0.4089 |
| APOE4(-); 23AC, 25PL | 4.17 | 4.68 | 0.51(-0.30, 1.32) | 0.2180 |
| APOE4(+); 33AC, 29PL | 4.48 | 4.38 | -0.10(-0.82, 0.61) | 0.7698 |
| ADAS-Cog; randomized only w/LOCF | ||||
| ITT; 61AC, 62PL | -0.093 | 0.908 | 1.00(-0.68, 2.70) | 0.2420 |
| APOE4(-); 24AC, 26PL | -1.070 | 1.614 | 2.68(0.05, 5.32) | 0.0457 |
| APOE4(+); 31AC, 30PL | 1.086 | 0.322 | 0.76(-1.62, 3.14) | 0.5265 |
| Day 104 Mean Change from Baseline | ||||
| ADAS-Cog; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | -0.113 | 0.636 | 0.75(-1.02, 2.52) | 0.4046 |
| APOE4(-); 29AC, 26PL | -0.736 | 1.336 | 2.07(-0.79, 4.93) | 0.1540 |
| APOE4(+); 38AC, 31PL | 0.544 | 0.290 | -0.25(-2.82, 2.31) | 0.8450 |
| MMSE; ITT w/LOCF | ||||
| ITT; 77AC, 63PL | -0.351 | -0.619 | -0.27(-1.33, 0.79) | 0.6177 |
| APOE4(-); 29AC, 26PL | -0.586 | -0.385 | 0.20(-1.52, 1.92) | 0.8166 |
| APOE4(+); 38AC, 31PL | -0.368 | -0.968 | -0.60(-2.14, 0.94) | 0.4421 |
| CGIC†; ITT w/LOCF | ||||
| ITT; 75AC, 63PL | 4.65 | 4.81 | 0.16(-0.29, 0.60)) | 0.4915 |
| APOE4(-); 28AC, 26PL | 4.39 | 5.00 | 0.61(-0.09, 1.31) | 0.0877 |
| APOE4(+); 37AC, 31PL | 4.73 | 4.48 | -0.25(-0.87, 0.31) | 0.4369 |
| ADAS-Cog; randomized only w/LOCF | ||||
| ITT; 61AC, 62PL | 0.022 | 0.431 | 0.41(-1.43, 2.25) | 0.6597 |
| APOE4(-); 24AC, 26PL | -0.583 | 1.336 | 1.92(-0.99, 4.83) | 0.1937 |
| APOE4(+); 31AC, 30PL | 0.398 | -0.144 | 0.54(-2.09, 3.17) | 0.6838 |
ITT = Intention-To-Treat; AC = AC-1202; PL = Placebo.
*2 way ANOVA calculated using PROC GLM Type 3 SS. P-values of differences of the type 3 SS LSMEANS.
†CGIC Mean Total scores at Days 45, 90 and 104. Note, some participants did not complete a Day 45 CGIC and no value was carried forward to Day 90.