Table 3.
Percent changes in cerebrospinal fluid amyloid-β fragment 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 Aβ1–37 (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) | ||
Abbreviations: AD Alzheimer’s disease, Aβ Amyloid-beta, CSF Cerebrospinal fluid, LS Least squares