Table 5 |
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|
Efficacy by visit and genotype in the ITT w/LOCF population* |
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|
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. |
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|
Henderson et al. Nutrition & Metabolism 2009 6:31 doi:10.1186/1743-7075-6-31 |
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