Table 7 |
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|
Efficacy by visit and genotype in the dosage compliant population* |
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|
Group; N |
AC-1202 |
Placebo |
Difference (95% CI) |
p-value |
|
|
||||
|
Day 45 Mean Change From Baseline |
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|
|
||||
|
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. |
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|
Henderson et al. Nutrition & Metabolism 2009 6:31 doi:10.1186/1743-7075-6-31 |
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