TABLE 1.
Baseline characteristics.
| CORE | OLE | |||||||
|---|---|---|---|---|---|---|---|---|
| Lecanemab | ||||||||
| Category | Placebo (N = 245) | 2.5 mg/kg Biweekly (N = 52) | 5 mg/kg Monthly (N = 51) | 5 mg/kg Biweekly (N = 92) | 10 mg/kg Monthly (N = 253) | 10 mg/kg Biweekly (N = 161) | Lecanemab 10 mg/kg Biweekly (N = 180) | |
| Age (year) | Mean (SD) | 71.1 (8.9) | 70.5 (8.3) | 70.5 (7.3) | 70.6 (7.4) | 71.2 (7.5) | 72.7 (8.7) | 74.0 (7.69) |
| Sex, n (%) | Female | 138 (56.3) | 26 (50.0) | 26 (51.0) | 50 (54.3) | 112 (44.3) | 70 (43.5) | 87 (48.3) |
| Region, n (%) | North America | 201 (82.0) | 47 (90.4) | 43 (84.3) | 73 (79.3) | 222 (87.7) | 142 (88.2) | 139 (77.2) |
| Western Europe | 28 (11.4) | 4 (7.7) | 7 (13.7) | 7 (7.6) | 15 (5.9) | 12 (7.5) | 12 (6.7) | |
| Asia | 16 (6.5) | 1 (1.9) | 1 (2.0) | 12 (13.0) | 16 (6.3) | 7 (4.3) | 29 (16.1) | |
| CDR‐Global, n (%) | 0.5 | 200 (84.0) | 44 (84.6) | 40 (83.3) | 77 (86.5) | 210 (85.4) | 133 (87.5) | 80 (44.4) |
| 1 | 38 (16.0) | 8 (15.4) | 8 (16.7) | 12 (13.5) | 36 (14.6) | 19 (12.5) | 68 (37.8) | |
| ApoE4 status, n (%) | Carrier | 174 (71.0) | 38 (73.1) | 40 (78.4) | 84 (91.3) | 225 (88.9) | 49 (30.4) | 125 (69.4) |
| Heterozygous | 134 (54.7) | 33 (63.5) | 28 (54.9) | 70 (76.1) | 165 (65.2) | 39 (24.2) | 97 (53.9) | |
| Homozygous | 40 (16.3) | 5 (9.6) | 12 (23.5) | 14 (15.2) | 60 (23.7) | 10 (6.2) | 28 (15.6) | |
| Noncarrier | 71 (29.0) | 14 (26.9) | 11 (21.6) | 8 (8.7) | 28 (11.1) | 112 (69.6) | 55 (30.6) | |
| ADCOMS | Mean (SD) | 0.370 (0.1663) | 0.386 (0.1970) | 0.395 (0.1746) | 0.390 (0.1558) | 0.373 (0.1522) | 0.373 (0.1508) | 0.651 (0.3685) |
| CDR‐SB | Mean (SD) | 2.89 (1.454) | 2.98 (1.584) | 2.94 (1.420) | 3.03 (1.314) | 2.91 (1.320) | 2.97 (1.401) | 5.28 (3.514) |
| ADAS‐cog14 | Mean (SD) | 22.56 (7.657) | 22.72 (8.050) | 22.94 (7.735) | 22.75 (6.696) | 21.90 (7.302) | 22.06 (7.667) | 35.105 (13.9699) |
| MMSE | Mean (SD) | 26.01 (2.348) | 25.67 (2.487) | 25.25 (2.622) | 25.60 (2.260) | 25.71 (2.364) | 25.61 (2.351) | 20.7 (6.64) |
Abbreviations: ADAS‐cog, Alzheimer's Disease Assessment Scale‐cognitive subscale; ADCOMS, Alzheimer's Disease Composite Score; CDR, clinical dementia rating; CDR‐SB, Clinical Dementia Rating Scale sum of boxes; MMSE, Mini‐Mental State Examination; OLE, open label extension.