Category | CORE | OLE | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Lecanemab | Lecanemab | |||||||||
Placebo (N=238) | 2.5 mg/kg biweekly (N=52) | 5 mg/kg monthly (N=48) | 5 mg/kg biweekly (N=89) | 10 mg/kg monthly (N=246) | 10 mg/kg biweekly (N=152) | Prior core placebo (N=42) | Prior core 10 mg/kg biweekly (N=37) | 10 mg/kg biweekly (N=180) | ||
Age (year)a | Mean (SD) | 71.1 (8.9) | 70.5 (8.3) | 70.4 (7.5) | 70.6 (7.4) | 71.3 (7.5) | 72.6 (8.8) | 71.8 (8.2) | 76.9 (7.0) | 74.0 (7.7) |
Sex, n (%) | Female | 137 (57.6) | 26 (50.0) | 24 (50.0) | 48 (53.9) | 110 (44.7) | 64 (42.1) | 21 (50.0) | 18 (48.6) | 87 (48.3) |
Region, n (%) | North America | 195 (81.9) | 47 (90.4) | 41 (85.4) | 70 (78.7) | 215 (87.4) | 135 (88.8) | 30 (71.4) | 32 (86.5) | 139 (77.2) |
Western Europe | 28 (11.8) | 4 (7.7) | 6 (12.5) | 7 (7.9) | 15 (6.1) | 10 (6.6) | 3 (7.1) | 2 (5.4) | 12 (6.7) | |
Asia Pacific | 15 (6.3) | 1 (1.9) | 1 (2.1) | 12 (13.5) | 16 (6.5) | 7 (4.6) | 9 (21.4) | 3 (8.1) | 29 (16.1) | |
Amyloid PET SUVr* | Mean (SD) | 1.4 (0.2) | 1.4 (0.1) | 1.4 (0.2) | 1.4 (0.1) | 1.4 (0.2) | 1.4 (0.2) | 1.4 (0.2) | 1.1 (0.1) | 1.2 (0.2) |
Amyloid Centiloids* | Mean (SD) | 84.8 (37.4) | 87.7 (26.4) | 89.4 (39.7) | 84.9 (28.0) | 90.3 (41.5) | 78.0 (38.0) | 77.2 (42.0) | 8.6 (30.9) | 44.5 (43.9) |
CDR-Global, n (%) | 0.5 | 200 (84.0) | 44 (84.6) | 40 (83.3) | 77 (86.5) | 210 (85.4) | 133 (87.5) | 19 (45.2) | 19 (51.4) | 80 (44.4) |
1 | 38 (16.0) | 8 (15.4) | 8 (16.7) | 12 (13.5) | 13 (14.6) | 19 (12.5) | 18 (42.9) | 11 (29.7) | 68 (37.8) | |
CDR-SB | Mean (SD) | 2.9 (1.5) | 3.0 (1.6) | 2.9 (1.4) | 3.0 (1.3) | 2.9 (1.3) | 3.0 (1.4) | 4.7 (3.2) | 5.0 (3.7) | 5.3 (3.5) |
ApoE4 status, n (%) | Carrier | 169 (71.0) | 38 (73.1) | 37 (77.1) | 81 (91.0) | 218 (88.6) | 46 (30.3) | 30 (71.4) | 3 (8.1) | 125 (69.4) |
Heterozygous | 129 (54.2) | 33 (63.5) | 26 (54.2) | 67 (75.3) | 160 (65.0) | 38 (25.0) | 4 (9.5) | 0 | 97 (53.9) | |
Homozygous | 40 (16.8) | 5 (9.6) | 11 (22.9) | 14 (15.7) | 58 (23.6) | 8 (5.3) | 26 (61.9) | 3 (8.1) | 28 (15.6) | |
Noncarrier | 69 (29.0) | 14 (26.9) | 11 (22.9) | 8 (9.0) | 28 (11.4) | 106 (69.7) | 12 (28.6) | 34 (91.9) | 55 (30.6) | |
Disease stage, n (%) | MCI due to AD | 154 (64.7) | 34 (65.4) | 33 (68.8) | 52 (58.4) | 166 (67.5) | 90 (59.2) | 27 (64.3) | 22 (59.5) | 110 (61.1) |
Mild AD | 84 (35.3) | 18 (34.6) | 15 (31.3) | 37 (41.6) | 80 (32.5) | 62 (40.8) | 15 (35.7) | 15 (40.5) | 70 (38.9) | |
ADCOMS | Mean (SD) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.4 (0.2) | 0.6 (0.3) | 0.6 (0.4) | 0.7 (0.4) |
ADAS-cog14 | Mean (SD) | 22.6 (7.7) | 22.7 (8.1) | 22.9 (7.7) | 22.8 (6.7) | 21.9 (7.3) | 22.1 (7.7) | 33.4 (13.5) | 32.5 (13.8) | 35.1 (14.0) |
MMSE | Mean (SD) | 26.0 (2.3) | 25.7 (2.5) | 25.3 (2.6) | 25.6 (2.3) | 25.7 (2.4) | 25.6 (2.4) | 21.5 (6.3) | 21.2 (6.0) | 20.7 (6.6) |