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Table 2 Secondary and exploratory efficacy analyses: change from baseline to week 78

From: Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials

 

ApoE ε4 carrier study

ApoE ε4 noncarrier study

PBO (n = 431)

BAP 0.5 (n = 650)

PBO (n = 328)

BAP 0.5 (n = 255)

BAP 1.0 (n = 253)

CDR-SOB total scorea

     

 Number of subjects

310

427

144

115

110

 Mean change (SD)

2.4 (2.8)

2.3 (2.9)

2.5 (2.8)

2.2 (2.8)

2.2 (2.6)

 MMRM analysis

     

  LS mean change (SE)

2.59 (0.16)

2.44 (0.13)

2.59 (0.20)

2.23 (0.23)

2.41 (0.23)

  Difference vs PBO

 

−0.15

 

−0.36

−0.18

   p Value

 

0.448

 

0.238

0.564

DS total scoreb

     

 Number of subjects

316

437

145

121

112

 Mean change (SD)

1.2 (2.2)

1.2 (2.3)

1.4 (2.5)

1.3 (2.0)

1.1 (2.5)

 MMRM analysis

     

  LS mean change (SE)

1.33 (0.1)

1.22 (0.1)

1.45 (0.17)

1.29 (0.19)

1.16 (0.19)

  Difference vs PBO

 

−0.11

 

−0.16

−0.29

   p Value

 

0.462

 

0.516

0.257

NTB total Z-scorec

     

 Number of subjects

296

403

120

105

96

 Mean change (SD)

0.0 (0.5)

0.0 (0.6)

−0.1 (0.5)

0 (0.5)

0 (0.4)

 MMRM analysis

     

  LS mean change (SE)

−0.11 (0.03)

−0.10 (0.02)

−0.09 (0.04)

0.02 (0.04)

−0.12 (0.04)

  Difference vs PBO

 

0.01

 

0.10

−0.03

   p Value

 

0.889

 

0.047

0.541

  1. ApoE apolipoprotein E, BAP bapineuzumab, CDR-SOB Clinical Dementia Rating–Sum of Boxes, DS Dependence Scale, LS least squares, MMRM mixed model for repeated measures, NTB Neuropsychological Test Battery, PBO placebo
  2. aCDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates improvement
  3. bDS total score range is 0–15, with higher scores indicating worse impairment; a negative change from baseline indicates improvement
  4. cPositive change indicates improvement in NTB total Z-score
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Alzheimer's Research & Therapy

ISSN: 1758-9193