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Table 6 Efficacy by visit and genotype in the per protocol 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     
   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
  1. PP = per protocol; 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.