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Table 7 Efficacy by visit and genotype in the dosage compliant 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

    

   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

  1. DC = Dosage Compliant; 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.
  4. Note, since this table uses non-imputed data, the number of subjects varies by Visit.