Table 7.
Efficacy by visit and genotype in the dosage compliant population*
| Group; N | AC-1202 | Placebo | Difference (95% CI) | p-value |
| Day 45 Mean Change From Baseline | ||||
| ADAS-Cog | ||||
| DC; 46AC, 50PL | -0.964 | 1.639 | 2.60(0.39, 4.81) | 0.0215 |
| APOE4(-); 16AC, 20PL | -3.063 | 3.198 | 6.26(2.59, 9.94) | 0.0011 |
| APOE4(+); 24AC, 24PL | 0.361 | 0.750 | 0.39(-2.77, 3.55) | 0.8073 |
| MMSE | ||||
| DC; 46AC, 50PL | 0.326 | -0.220 | 0.55(-0.57, 1.66) | 0.3342 |
| APOE4(-); 16AC, 20PL | -0.313 | 0.350 | 0.66(-1.12, 2.45) | 0.4622 |
| APOE4(+); 24AC, 24PL | 0.500 | -0.917 | 1.42(-0.12, 2.95) | 0.0701 |
| CGIC† | ||||
| DC; 44AC, 48PL | 4.114 | 4.313 | 0.20(-0.32, 0.72) | 0.4481 |
| APOE4(-); 16AC, 19PL | 4.063 | 4.895 | 0.83(0.00, 1.66) | 0.0500 |
| APOE4(+); 22AC, 23PL | 4.182 | 3.652 | 0.53(-0.20, 1.26) | 0.1533 |
| Day 90 Mean Change From Baseline | ||||
| ADAS-Cog | ||||
| DC; 44AC, 48PL | -1.182 | 1.076 | 2.26(-0.14, 4.65) | 0.0641 |
| APOE4(-); 16AC, 19PL | -3.854 | 1.472 | 5.33(1.55, 9.11) | 0.0063 |
| APOE4(+); 22AC, 24PL | 0.909 | 0.833 | 0.08(-3.21, 3.36) | 0.9635 |
| MMSE | ||||
| DC; 44AC, 48PL | -0.136 | -0.271 | 0.13(-1.1, 1.36) | 0.8275 |
| APOE4(-); 16AC, 19PL | -0.125 | 0.789 | 0.91(-1.09, 2.92) | 0.3656 |
| APOE4(+); 22AC, 24PL | -0.136 | -1.083 | 0.95(-0.79, 2.69) | 0.2820 |
| CGIC† | ||||
| DC; 43AC, 48PL | 4.535 | 4.521 | 0.01(-0.56, 0.59) | 0.9613 |
| APOE4(-); 16AC, 19PL | 4.125 | 4.474 | 0.35(-0.59, 1.29) | 0.4613 |
| APOE4(+); 21AC, 24PL | 4.714 | 4.375 | 0.34(-0.49, 1.17) | 0.4158 |
| Day 104 Mean Change From Baseline | ||||
| ADAS-Cog | ||||
| DC; 43AC, 47PL | -0.969 | 0.682 | 1.65(-0.75, 4.05) | 0.1751 |
| APOE4(-); 16AC, 19PL | -1.875 | 1.389 | 3.26(-0.72, 7.25) | 0.1070 |
| APOE4(+); 21AC, 23PL | 0.111 | 0.449 | 0.34(-3.21, 3.88) | 0.8498 |
| MMSE | ||||
| DC; 43AC, 47PL | 0.186 | -0.766 | 0.95(-0.48, 2.38) | 0.1901 |
| APOE4(-); 16AC, 19PL | -0.313 | 0.000 | 0.31(-2.03, 2.66) | 0.7916 |
| APOE4(+); 21AC, 23PL | 0.524 | -1.565 | 2.09(0.00, 4.18) | 0.0499 |
| CGIC† | ||||
| DC; 42AC, 46PL | 4.667 | 4.804 | 0.14(-0.42, 0.70) | 0.6248 |
| APOE4(-); 15AC, 19PL | 4.267 | 4.895 | 0.63(-0.24, 1.50) | 0.1547 |
| APOE4(+); 21AC, 22PL | 4.857 | 4.455 | 0.40(-0.37, 1.17) | 0.3002 |
DC = Dosage Compliant; 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, since this table uses non-imputed data, the number of subjects varies by Visit.