Table 2 Percent changes in cerebrospinal fluid and plasma amyloid-β 1–40 levels from baseline at day 28 across treatment groups
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 Aβ1–40 (ng/L), n | 13 | 14 | 15 | 6 | 6 | 6 |
Mean (SD) | 3.33 (12.389) | − 67.30 (10.602) | − 89.93 (3.535) | − 7.36 (12.122) | − 68.21 (16.174) | − 87.15 (3.898) |
Median (range) | − 0.30 (− 10.3; 32.9) | − 65.22 (− 89.7; − 53.6) | − 90.66 (− 97.8; − 85.9) | − 9.18 (− 21.7; 9.0) | − 61.36 (− 99.9; − 57.7) | − 86.91 (− 92.2; − 81.5) |
95% CI of mean | (− 4.16; 10.82) | (− 73.42; − 61.18) | (− 91.89; − 87.97) | (− 20.08; 5.36) | (− 85.18; − 51.23) | (− 91.24; − 83.06) |
LS mean | 2.73 | − 66.65 | − 90.01 | − 6.48 | − 68.96 | − 87.29 |
Difference of LS means (SE) | – | − 69.37 (3.890) | − 92.74 (3.630) | – | − 62.48 (7.386) | − 80.81 (7.145) |
95% CI | – | (− 72.25; − 61.50) | (− 100.08; − 85.39) | – | (− 78.32; − 46.64) | (− 96.13; − 65.49) |
Plasma Aβ1–40 (ng/L) (4 hours postdose), n | 14 | 15 | 16 | 6 | 6 | 6 |
Mean (SD) | − 9.36 (27.288) | − 83.78 (6.022) | − 92.89 (3.117) | − 11.79 (8.047) | − 82.73 (3.508) | − 91.49 (4.403) |
Median (range) | − 2.37 (− 87.3; 29.2) | − 84.83 (− 95.3; − 72.4) | − 94.13 (− 95.6; − 86.3) | − 8.98 (− 23.0; −3.2) | − 82.48 (− 88.8; − 78.7) | − 91.01 (− 96.3; − 84.3) |
95% CI of mean | (− 25.12; 6.39) | (− 87.11; − 80.44) | (− 94.55; − 91.23) | (− 20.24; − 3.35) | (− 86.41; − 79.05) | (− 96.11; − 86.87) |
LS mean | − 9.65 | − 83.45 | − 92.95 | − 11.79 | − 82.73 | − 91.49 |
Difference of LS means (SE) | − 73.80 (6.058) | − 83.30 (5.820) | – | − 70.94 (3.394) | − 79.70 (3.390) | |
95% CI | (− 86.04; − 61.57) | (− 95.06; − 71.55) | – | (− 78.22; − 63.66) | (− 86.97; − 72.43) | |