|
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)
|
- Abbreviations: AD Alzheimer’s disease, Aβ Amyloid-beta, CSF Cerebrospinal fluid, LS Least squares
