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Table 2 Double-blind secondary efficacy: change from baseline to final analysis from repeated-measures analyses

From: ABT-126 monotherapy in mild-to-moderate Alzheimer’s dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension

  Baseline Week 24, n Change from BL to week 24 Difference from placebo  
n Observed mean (SD) Mean (SD) LS mean ± SE LS mean ± SE 90 % CI P value
Alzheimer’s Disease Assessment Scale—Cognitive subscale, 13-item total score (↓ indicates improvement)
 Placebo 98 38.26 (12.66) 88 −0.76 (6.99) −0.67 ± 0.71    
 ABT-126 25 mg 71 35.05 (13.06) 63 −1.41 (6.82) −1.14 ± 0.84 −0.47 ± 1.08 −2.25, 1.31 0.333
 ABT-126 50 mg 100 36.71 (12.52) 87 −2.12 (6.41) −1.70 ± 0.71 −1.03 ± 0.98 −2.65, 0.60 0.149
 ABT-126 75 mg 68 39.11 (10.72) 61 −2.32 (6.07) −1.87 ± 0.84 −1.19 ± 1.09 −2.98, 0.60 0.137
 Donepezil 68 39.18 (14.13) 59 −3.56 (6.69) −3.54 ± 0.87 −2.86 ± 1.10 −4.67, −1.05 0.005*
Mini-Mental Status Examination score (↑ indicates improvement)
 Placebo 98 18.97 (4.01) 89 0.56 (2.83) 0.39 ± 0.32    
 ABT-126 25 mg 72 20.08 (4.04) 64 0.19 (3.13) −0.16 ± 0.38 −0.55 ± 0.49 −1.36, 0.27 0.866
 ABT-126 50 mg 102 18.70 (3.92) 92 0.86 (3.38) 0.78 ± 0.32 0.39 ± 0.44 −0.34, 1.12 0.191
 ABT-126 75 mg 69 18.39 (3.88) 62 0.74 (3.17) 0.53 ± 0.38 0.14 ± 0.49 −0.68, 0.95 0.390
 Donepezil 69 18.59 (4.42) 59 1.29 (2.76) 1.19 ± 0.39 0.80 ± 0.50 −0.02, 1.62 0.055
Clinician Interview-Based Impression of Severity and Clinician Interview-Based Impression of Change—Plusa
 Placebo 98 3.64 (0.79) 89 4.15 (0.83) 4.18 ± 0.09    
 ABT-126 25 mg 73 3.77 (0.86) 64 4.03 (0.73) 4.06 ± 0.10 −0.12 ± 0.13 −0.33, 0.10 0.184
 ABT-126 50 mg 102 3.63 (0.87) 92 3.95 (0.87) 4.03 ± 0.08 −0.15 ± 0.12 −0.34, 0.05 0.105
 ABT-126 75 mg 68 3.75 (0.82) 61 3.77 (0.84) 3.80 ± 0.10 −0.38 ± 0.13 −0.59, −0.16 0.002*
 Donepezil 69 3.88 (0.81) 59 3.68 (0.78) 3.75 ± 0.10 −0.43 ± 0.13 −0.65, −0.21 <0.001*
Neuropsychiatric Inventory, 10-item total score (↓ indicates improvement)
 Placebo 98 8.64 (8.70) 89 0.18 (6.27) −0.26 ± 0.82    
 ABT-126 25 mg 73 9.21 (8.93) 64 −1.72 (7.81) −1.09 ± 0.96 −0.82 ± 1.23 −2.86, 1.21 0.252
 ABT-126 50 mg 102 8.30 (8.07) 93 −0.59 (9.78) −0.50 ± 0.81 −0.24 ± 1.11 −2.07, 1.60 0.416
 ABT-126 75 mg 69 10.57 (11.31) 62 −0.98 (7.26) −0.13 ± 0.96 0.14 ± 1.25 −1.92, 2.19 0.544
 Donepezil 69 12.39 (11.63) 59 −3.27 (9.87) −2.72 ± 0.99 −2.45 ± 1.26 −4.53, −0.38 0.026*
Neuropsychiatric Inventory, 12-item total score (↓ indicates improvement)
 Placebo 98 10.17 (9.66) 89 0.30 (7.67) −0.11 ± 0.95    
 ABT-126 25 mg 73 11.19 (10.45) 64 −1.91 (9.84) −0.92 ± 1.11 −0.81 ± 1.44 −3.17, 1.56 0.287
 ABT-126 50 mg 102 9.43 (8.55) 93 −0.03 (11.12) 0.05 ± 0.94 0.16 ± 1.30 −1.98, 2.30 0.549
 ABT-126 75 mg 69 12.19 (12.93) 62 −1.52 (8.01) −0.54 ± 1.12 −0.43 ± 1.45 −2.82, 1.96 0.383
 Donepezil 69 13.41 (12.77) 59 −3.10 (10.82) −2.67 ± 1.15 −2.55 ± 1.46 −4.96, −0.15 0.041*
Alzheimer’s Disease Cooperative Study—Activity of Daily Living total score (↑ indicates improvement)
 Placebo 98 56.46 (14.17) 89 −1.79 (8.16) −2.30 ± 0.76    
 ABT-126 25 mg 73 57.15 (16.35) 64 0.28 (6.65) −0.44 ± 0.89 1.86 ± 1.14 −0.03, 3.74 0.053
 ABT-126 50 mg 102 55.97 (14.96) 93 0.18 (7.13) 0.00 ± 0.75 2.30 ± 1.04 0.60, 4.01 0.013*
 ABT-126 75 mg 69 54.30 (14.65) 62 −0.21 (7.18) −0.44 ± 0.90 1.86 ± 1.15 −0.04, 3.76 0.054
 Donepezil 69 52.00 (14.11) 59 2.14 (5.60) 1.71 ± 0.92 4.01 ± 1.16 2.09, 5.93 <0.001*
  Baseline Week 18, n Change from BL to week 18 Difference from placebo  
n Observed mean (SD) Mean (SD) LS mean ± SE LS mean ± SE 90 % CI P value
Wechsler Memory Scale—III Working Memory Index total score (↑ indicates improvement)
 Placebo 93 74.02 (13.28) 91 2.04 (11.21) 1.17 ± 1.11    
 ABT-126 25 mg 68 78.50 (17.02) 65 0.83 (11.38) 0.24 ± 1.31 −0.93 ± 1.64 −3.63, 1.77 0.715
 ABT-126 50 mg 99 75.57 (13.40) 93 −0.42 (11.32) −1.73 ± 1.10 −2.91 ± 1.48 −5.34, −0.47 0.975
 ABT-126 75 mg 66 77.85 (15.40) 64 −1.66 (10.66) −2.34 ± 1.27 −3.52 ± 1.65 −6.23, −0.80 0.983
 Donepezil 61 75.66 (15.54) 61 1.82 (8.88) 1.31 ± 1.35 0.13 ± 1.65 −2.60, 2.86 0.468
  1. *One-sided P value statistically significant vs placebo
  2. aClinician Interview-Based Impression of Severity at baseline and Clinician Interview-Based Impression of Change—Plus at subsequent visits. Clinician Interview-Based Impression of Change—Plus ratings range from 1 = markedly improved to 7 = markedly worse. LS means (SE) are presented instead of LS mean (SE) of change
  3. BL baseline (last assessment taken on or before the day –1 visit), LS least squares, SD standard deviation, SE standard error