Table 1.
Patient Demographics and Baseline Characteristics
| US subgroup |
RoW subgroup |
|||
|---|---|---|---|---|
| Donepezil 23 mg/d | Donepezil 10 mg/d | Donepezil 23 mg/d | Donepezil 10 mg/d | |
| Safety population | 308 | 146 | 655 | 325 |
| Age, years a | ||||
| Mean (SD) | 74.5 (8.7) | 75.0 (8.2) | 73.5 (8.4) | 73.3 (8.7) |
| Gender, n (%) | ||||
| Male | 114 (37.0) | 52 (35.6) | 242 (36.9) | 125 (38.5) |
| Female | 194 (63.0) | 94 (64.4) | 413 (63.1) | 200 (61.5) |
| BMI b | ||||
| Mean (SD) | 26.0 (4.7) | 25.9 (4.7) | 24.8 (4.2) | 24.6 (4.0) |
| Education, years b | ||||
| Mean (SD) | 13.3 (3.1) | 13.1 (2.4) | 9.5 (4.6) | 9.7 (4.7) |
| Race, n (%) c | ||||
| White | 268 (87.0) | 129 (88.4) | 440 (67.2) | 217 (66.8) |
| Black | 22 (7.1) | 9 (6.2) | 0 (0.0) | 0 (0.0) |
| Hispanic | 18 (5.8) | 7 (4.8) | 49 (7.5) | 19 (5.8) |
| Asian/Pacific | 0 (0.0) | 1 (0.7) | 161 (24.6) | 86 (26.5) |
| Other | 0 (0.0) | 0 (0.0) | 5 (0.8) | 3 (0.9) |
| Residence status, n (%) c | ||||
| Lives with caregiver | 249 (80.8) | 107 (73.3) | 531 (81.1) | 258 (79.4) |
| Lives with relative/friend | 26 (8.4) | 12 (8.2) | 71 (10.8) | 33 (10.2) |
| Lives alone | 13 (4.2) | 8 (5.5) | 21 (3.2) | 22 (6.8) |
| Assisted living facility | 13 (4.2) | 17 (11.6) | 7 (1.1) | 3 (0.9) |
| Senior residence | 3 (1.0) | 2 (1.4) | 11 (1.7) | 3 (0.9) |
| Skilled nursing facility | 3 (1.0) | 0 (0.0) | 4 (0.6) | 2 (0.6) |
| Intermediate nursing facility | 0 (0.0) | 0 (0.0) | 3 (0.5) | 0 (0.0) |
| Other | 1 (0.3) | 0 (0.0) | 7 (1.1) | 4 (1.2) |
| Prior duration of 10 mg, weeks b | ||||
| Mean (SD) | 167.5 (120.7) | 166.7 (118.0) | 86.1 (90.9) | 76.0 (74.0) |
| Concomitant memantine at baseline, n (%) d | 231 (75.0) | 108 (74.0) | 121 (18.5) | 60 (18.5) |
| SIB | ||||
| Mean (SD) | 73.3 (20.1) | 76.1 (15.8) | 74.8 (16.2) | 75.1 (16.7) |
| MMSE b | ||||
| Mean (SD) | 12.2 (5.3) | 12.4 (4.9) | 13.6 (4.8) | 13.3 (4.6) |
| ADCS-ADL-sev | ||||
| Mean (SD) | 34.5 (11.1) | 35.0 (10.9) | 33.9 (10.9) e | 34.3 (11.4) |
| CIBIS-plus f | ||||
| Mean (SD) | 4.50 (0.89) | 4.48 (0.84) | 4.37 (0.83) | 4.35 (0.91) |
Abbreviations: ADCS-ADL-sev, Alzheimer’s Disease Cooperative Study-Activities of Daily Living-severe version; BMI, body mass index; CIBIS-plus, Clinician’s Interview-Based Impression of Severity-plus caregiver input; MMSE, Mini-Mental State Examination; SIB, Severe Impairment Battery; RoW, rest of the world; SD, standard deviation.
a P < .05 for US subgroup (all patients) versus RoW subgroup (all patients); standard 2-sample t test.
b P < .001 for US subgroup (all patients) versus RoW subgroup (all patients); standard 2-sample t test.
c P < .001 for US subgroup (all patients) versus RoW subgroup (all patients); χ2 test.
d P < .001 for US subgroup (all patients) versus RoW subgroup (all patients); χ2 test.
e Based on 644 patients with available baseline ADCS-ADL-sev data.
f P < .01 for US subgroup (all patients) versus RoW subgroup (all patients); standard 2-sample t test.