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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.
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Nutrition & Metabolism

ISSN: 1743-7075

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