Table 6 |
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|
Efficacy by visit and genotype in the per protocol population* |
||||
|
Group; N |
AC-1202 |
Placebo |
Difference (95% CI) |
p-value |
|
|
||||
|
Day 45 Mean Change From Baseline |
||||
|
|
||||
|
ADAS-Cog |
||||
|
PP; 45AC, 46PL |
-0.600 |
1.927 |
2.53(0.22, 4.84) |
0.0324 |
|
APOE4(-); 18AC, 19PL |
-2.259 |
3.472 |
5.73(2.05, 9.41) |
0.0027 |
|
APOE4(+); 20AC, 23PL |
0.783 |
0.913 |
0.13(-3.29, 3.55) |
0.9400 |
|
MMSE |
||||
|
PP; 45AC, 46PL |
0.378 |
-0.217 |
0.60(-0.55, 1.74) |
0.3060 |
|
APOE4(-); 18AC, 19PL |
0.000 |
0.316 |
0.32(-1.44, 2.07) |
0.7207 |
|
APOE4(+); 20AC, 23PL |
0.350 |
-0.826 |
1.18(-0.45, 2.81) |
0.1546 |
|
CGIC† |
||||
|
PP; 45AC, 46PL |
4.00 |
4.26 |
0.26(-0.24, 0.76) |
0.3040 |
|
APOE4(-); 18AC, 19PL |
3.94 |
4.89 |
0.95(0.20, 1.70) |
0.0142 |
|
APOE4(+); 20AC, 23PL |
4.15 |
3.61 |
0.54(-0.16, 1.24) |
0.1283 |
|
|
||||
|
Day 90 Mean Change From Baseline |
||||
|
|
||||
|
ADAS-Cog |
||||
|
PP; 45AC, 46PL |
-0.563 |
0.956 |
1.52(-0.78, 3.82) |
0.1923 |
|
APOE4(-); 18AC, 19PL |
-2.426 |
1.963 |
4.39(0.90, 7.87) |
0.0143 |
|
APOE4(+); 20AC, 23PL |
1.433 |
0.145 |
-1.29(-4.53, 1.95) |
0.4307 |
|
MMSE |
||||
|
PP; 45AC, 46PL |
-0.261 |
-0.178 |
0.08(-1.14, 1.30) |
0.8925 |
|
APOE4(-); 18AC, 19PL |
-0.056 |
0.684 |
0.74(-1.20, 2.68) |
0.4502 |
|
APOE4(+); 20AC, 23PL |
-0.350 |
-0.913 |
0.56(-1.24, 2.37) |
0.5362 |
|
CGIC† |
||||
|
PP; 45AC, 46PL |
4.31 |
4.61 |
0.29(-0.28, 0.87) |
0.3109 |
|
APOE4(-); 18AC, 19PL |
3.83 |
4.58 |
0.75(-0.15, 1.64) |
0.1006 |
|
APOE4(+); 20AC, 23PL |
4.65 |
4.43 |
0.22(-0.62, 1.04) |
0.6072 |
|
|
||||
|
Day 104 Mean Change From Baseline |
||||
|
|
||||
|
ADAS-Cog |
||||
|
PP; 45AC, 46PL |
-0.274 |
0.704 |
0.98(-1.35, 3.30) |
0.4055 |
|
APOE4(-); 18AC, 19PL |
-0.389 |
1.495 |
1.88(-1.87, 5.64) |
0.3206 |
|
APOE4(+); 20AC, 23PL |
0.117 |
0.188 |
0.07(-3.42, 3.56) |
0.9674 |
|
MMSE |
||||
|
PP; 45AC, 46PL |
0.444 |
-0.587 |
1.03(-0.18, 2.24) |
0.0941 |
|
APOE4(-); 18AC, 19PL |
-0.111 |
0.158 |
0.27(-1.65, 2.19) |
0.7813 |
|
APOE4(+); 20AC, 23PL |
1.000 |
-1.130 |
2.13(0.34, 3.92) |
0.0201 |
|
CGIC† |
||||
|
PP; 45AC, 46PL |
4.64 |
4.78 |
0.14(-0.44, 0.72) |
0.6368 |
|
APOE4(-); 18AC, 19PL |
4.22 |
4.89 |
0.67(-0.22, 1.56) |
0.1359 |
|
APOE4(+); 20AC, 23PL |
4.80 |
4.52 |
0.28(-0.55, 1.10) |
0.5043 |
|
|
||||
|
PP = per protocol; 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. |
||||
|
Henderson et al. Nutrition & Metabolism 2009 6:31 doi:10.1186/1743-7075-6-31 |
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