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Table 1 Demographics and baseline characteristics

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

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  
1–40, 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)
1–42, 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)
1–37, 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)
1–38, 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)
1–42, 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)  
  1. Abbreviations: AD Alzheimer’s disease, APOE Apolipoprotein E, APP Amyloid precursor protein, Amyloid-beta, BMI Body mass index, CSF Cerebrospinal fluid, P-tau181 Phosphorylated tau, sAPP Soluble amyloid precursor protein, T-tau Total tau
  2. All individual assay values were below 600 ng/L
  3. aFour-plex assay data
  4. bScreening Innotest assay data