Table 6

Efficacy by visit and genotype in the per protocol population*

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


PP = per protocol; AC = AC-1202; PL = Placebo.

*2 way ANOVA calculated using PROC GLM Type 3 SS. P-values of differences of the type 3 SS LSMEANS.

CGIC Mean Total scores at Days 45, 90 and 104.

Henderson et al. Nutrition & Metabolism 2009 6:31   doi:10.1186/1743-7075-6-31

Open Data