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Table 3 Percent changes in cerebrospinal fluid amyloid-β fragment levels from baseline at day 28 across treatment groups

From: Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer’s disease: randomized, double-blind, placebo-controlled study

Safety analysis set Caucasian Japanese
Early AD Preclinical AD
Percent change from baseline at day 28 Placebo JNJ-54861911 Placebo JNJ-54861911
10 mg 50 mg 10 mg 50 mg
CSF Aβ1–37 (ng/L), n 12 15 14 4 2 3
 Mean (SD) 0.16 (10.753) − 66.87 (6.851) − 95.10 (4.501) − 19.45 (5.529) − 61.60 (3.741) − 89.82 (2.385)
 Median (range) 0.31 (− 19.8; 19.4) − 67.36 (− 81.1; − 52.1) − 96.62 (− 99.4; − 87.7) − 18.82 (− 26.2; − 14.0) − 61.60 (− 64.2; − 59.0) − 89.31 (− 92.4; − 87.7)
 95% CI of mean (− 6.68; 6.99) (− 70.67; 63.08) (− 97.70; − 92.50) (− 28.25; − 10.65) (− 95.22; − 27.99) (− 95.75; − 83.90)
 LS mean 0.29 − 66.94 − 95.13 − 19.89 − 62.45 − 88.67
 Difference of LS means (SE)   − 67.23 (3.103) − 95.42 (3.106)   − 42.55 (4.011) − 68.78 (4.105)
 95% CI   (− 73.52; − 60.94) (− 101.71; − 89.12)   (− 52.86; − 32.24) (− 79.33; − 58.23)
CSF Aβ1–38 (ng/L), n 13 15 15 6 6 6
 Mean (SD) − 5.58 (27.514) − 58.82 (7.183) − 87.93 (3.511) − 10.70 (7.618) − 62.37 (18.712) − 83.35 (4.890)
 Median (range) − 2.21 (− 91.3; 19.2) − 57.82 (− 76.5; − 50.9) − 88.88 (− 91.4; − 82.4) − 8.59 (− 21.8; − 3.0) − 57.12 (− 99.7; − 50.4) − 82.84 (− 88.9; − 76.1)
 95% CI of mean (− 22.20; 11.05) (− 62.80; − 54.85) (− 89.87; − 85.98) (− 18.69; − 2.70) (− 82.01; − 42.74) (− 88.48; − 78.22)
 LS mean −7.48 − 57.34 − 87.76 − 10.21 − 62.95 − 83.26
 Difference of LS means (SE)   − 49.86 (6.095) − 80.28 (5.920)   − 52.74 (7.746) − 73.05 (7.229)
 95% CI   (− 62.19; − 37.53) (− 92.25; − 68.31)   (− 69.35; − 36.12) (− 88.56; − 57.55)
CSF Aβ1–42 (ng/L), n 13 15 15 6 4 6
 Mean (SD) 2.36 (14.942) − 51.86 (11.611) − 82.48 (4.852) − 11.79 (10.105) − 61.22 (7.510) − 81.51 (3.076)
 Median (range) 1.08 (− 15.1; 41.7) − 52.08 (− 72.8; − 31.2) − 82.90 (− 90.4; − 73.5) − 11.52 (− 26.1; 2.0) − 60.78 (− 69.4; − 53.9) − 81.90 (− 84.9; − 78.1)
 95% CI of mean (− 6.66; 11.39) (− 58.29; − 45.43) (− 85.17; − 79.79) (− 22.39; − 1.18) (− 73.17; − 49.27) (− 84.74; − 78.28)
 LS mean 1.40 − 51.92 − 81.58 − 11.64 − 61.45 − 81.50
 Difference of LS means (SE)   − 53.32 (3.864) − 82.97 (3.905)   − 49.81 (5.191) − 69.86 (4.509)
 95% CI   (− 61.13; − 45.50) (− 90.87; − 75.07)   (− 61.12; − 38.50) (− 79.69; − 60.04)
  1. Abbreviations: AD Alzheimer’s disease, Amyloid-beta, CSF Cerebrospinal fluid, LS Least squares