Table 1.
Demographics and baseline characteristics
| Baseline characteristics | Caucasian | Japanese | ||||||
|---|---|---|---|---|---|---|---|---|
| Early AD (ALZ1005) | JNJ-54861911 total | Preclinical AD (ALZ1008) | JNJ-54861911 total | |||||
| Placebo | JNJ-54861911 | Placebo | JNJ-54861911 | |||||
| 10 mg | 50 mg | 10 mg | 50 mg | |||||
| No. of patients | 14 | 15 | 16 | 31 | 6 | 6 | 6 | 12 |
| Male sex, n (%) | 7 (50.0) | 11 (73.3) | 6 (37.5) | 17 (54.8) | 4 (66.7) | 5 (83.3) | 4 (66.7) | 9 (75.0) |
| Age years, mean (SD) | 70.4 (6.17) | 70.6 (4.48) | 67.6 (5.99) | 69.1 (5.44) | 74.3 (5.24) | 72.2 (3.06) | 69.8 (2.14) | 71.0 (2.80) |
| Race, Caucasian, n (%) | 14 (100.0) | 15 (100.0) | 16 (100.0) | 31 (100.0) | – | – | – | – |
| Race, Japanese, n (%) | – | – | – | – | 6 (100.0) | 6 (100.0) | 6 (100.0) | 12 (100.0) |
| Baseline height, cm, mean (SD) | 167.1 (11.25) | 166.8 (6.71) | 164.4 (10.52) | 165.6 (8.83) | 158.42 (6.070) | 164.00 (9.894) | 159.43 (12.163) | 161.72 (10.836) |
| Baseline BMI, kg/m2, mean (SD) | 24.5 (3.20) | 26.3 (3.26) | 25.3 (3.38) | 25.8 (3.31) | 23.49 (3.217) | 22.60 (0.925) | 22.39 (0.598) | 22.50 (0.751) |
| APOE ε4 carrier status, n (%) | ||||||||
| No | 3 (21.4) | 7 (46.7) | 7 (43.7) | – | 4 (66.7) | 3 (50.0) | 5 (83.3) | – |
| Yes | 11 (78.6) | 8 (53.3) | 9 (56.3) | – | 2 (33.3) | 3 (50.0) | 1 (16.7) | – |
| Baseline CSF biomarkers, n | 14 | 15 | 16 | 6 | 6 | 6 | ||
| Aβ1–40, ng/L, mean (SD)a | 6565.86 (2393.583) | 8982.57 (3811.543) | 7462.00 (2267.950) | – | 11,751.50 (4858.828) | 8780.17 (3964.651) | 9899.83 (2399.994) | – |
| Aβ1–42, ng/L, mean (SD)a | 426.86 (164.967) | 487.67 (211.560) | 538.53 (320.321) | 738.00 (149.689) | 583.00 (226.851) | 682.50 (258.667) | – | |
| Aβ1–37, ng/L, mean (SD)a | 648.43 (259.225) | 736.20 (228.065) | 709.50 (165.607) | 367.25 (83.112) | 346.50 (55.861) | 450.00 (62.386) | – | |
| Aβ1–38, ng/L, mean (SD)a | 2332.93 (684.261) | 2856.00 (850.390) | 2649.93 (501.609) | 2725.17 (1092.247) | 1956.00 (735.509) | 2435.83 (522.580) | – | |
| sAPP-α, μg/L, mean (SD) | 118.54 (50.009) | 130.27 (42.193) | 128.81 (24.222) | – | 175.00 (87.391) | 119.17 (85.558) | 159.50 (76.839) | – |
| sAPP-β, μg/L, mean (SD) | 153.23 (62.674) | 156.60 (52.257) | 178.56 (53.678) | – | 174.83 (88.529) | 124.33 (82.827) | 181.00 (84.024) | – |
| Total sAPP, μg/L, mean (SD) | 784.92 (378.593) | 924.87 (295.937) | 887.06 (187.804) | – | 1143.17 (534.634) | 685.17 (340.141) | 1040.00 (632.984) | – |
| T-tau, ng/L, mean (SD) | 524.62 (231.997) | 618.93 (277.427) | 616.40 (350.728) | – | 388.83 (297.941) | 338.00 (244.530) | 367.33 (65.025) | – |
| P-tau181, ng/L, mean (SD) | 72.58 (30.303) | 80.13 (25.368) | 82.29 (26.960) | – | 55.83 (35.397) | 49.50 (29.623) | 53.33 (7.659) | – |
| Aβ1–42, ng/L, mean (SD)b | 415.07 (86.442) | 413.80 (125.575) | 361.56 (77.099) | 487.17 (103.747) | 504.67 (95.320) | 503.17 (73.216) | ||
Abbreviations: AD Alzheimer’s disease, APOE Apolipoprotein E, APP Amyloid precursor protein, Aβ Amyloid-beta, BMI Body mass index, CSF Cerebrospinal fluid, P-tau181 Phosphorylated tau, sAPP Soluble amyloid precursor protein, T-tau Total tau
All individual assay values were below 600 ng/L
aFour-plex assay data
bScreening Innotest assay data