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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.