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Table 5 Efficacy by visit and genotype in the ITT w/LOCF population*

From: Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial

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
  1. ITT = Intention-To-Treat; AC = AC-1202; PL = Placebo.
  2. *2 way ANOVA calculated using PROC GLM Type 3 SS. P-values of differences of the type 3 SS LSMEANS.
  3. 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.