Skip to main content

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