Table 1.
Baseline Characteristics in Study 301, Study 302, and the Pooled Study 301 and 302 Data.
| Characteristics | Study 301 (N = 1245) | Study 302 (N = 1089) | Pooled 301 and 302 (N = 2334) |
|---|---|---|---|
| Age, mean (SD), yrs | 72.8 (9.6) | 72.1 (8.2) | 72.5 (9.0) |
| 50-59 yrs, n (%) | 160 (12.9) | 94 (8.6) | 254 (10.9) |
| 60-69 yrs, n (%) | 271 (21.8) | 280 (25.7) | 551 (23.6) |
| 70-79 yrs, n (%) | 442 (35.5) | 508 (46.6) | 950 (40.7) |
| 80-89 yrs, n (%) | 372 (29.9) | 207 (19.0) | 579 (24.8) |
| Female n (%) | 662 (53.2) | 599 (55.0) | 1261 (54.0) |
| Race, n (%) | |||
| White | 1182 (94.9) | 1043 (95.8) | 2225 (95.3) |
| Black or African American | 31 (2.5) | 32 (2.9) | 63 (2.7) |
| Asian | 11 (0.9) | 5 (0.5) | 16 (0.7) |
| American Indian or Alaska Native | 1 (0.1) | 3 (0.3) | 4 (0.2) |
| Native Hawaiian or other Pacific Islander | 1 (0.1) | 1 (0.0) | |
| Other | 19 (1.5) | 6 (0.6) | 25 (1.1) |
| Duration of AD, mean (SD), yrs | 3.1 (2.3) | 3.4 (2.4) | 3.2 (2.4) |
| APOE*∊4 allele copy number, n (%) | |||
| 0 | 1245 (100.0) | – | 1245 (53.3) |
| 1 | – | 819 (75.2) | 819 (35.1) |
| 2 | – | 270 (24.8) | 270 (11.6) |
| MMSE, mean (SD) | 21.2 (3.2) | 20.7 (3.2) | 21.0 (3.2) |
| Mild ≥ 21, n (%) | 713 (57.3) | 554 (50.9) | 1267 (54.3) |
| Moderate ≤ 20, n (%) | 532 (42.7) | 535 (49.1) | 1067 (45.7) |
| ADAS-cog, mean (SD) | 22.3 (9.8) | 23.7 (9.5) | 22.9 (9.7) |
| DAD, mean (SD) | 80.0 (18.9) | 80.3 (18.0) | 80.1 (18.5) |
| DS, mean (SD) | 4.6 (2.2) | 4.8 (2.0) | 4.7 (2.2) |
| CDR-SB, mean (SD) | 5.1 (2.9) | 5.2 (2.7) | 5.2 (2.8) |
| NPI, mean (SD) | 11.0 (12.4) | 10.1 (11.8) | 10.6 (12.1) |
| RUD-Lite v2.4 Total Caregiver Time, mean (SD) | 126.3 (183.0) | 122.1 (184.7) | 124.4 (183.8) |
| Equivalent Institutional Care (EIC), n (%) | |||
| Limited home care | 1012 (81.3) | 877 (80.5) | 1889 (80.9) |
| Adult home | 223 (17.9) | 202 (18.5) | 425 (18.2) |
| Health-related facility | 7 (0.6) | 6 (0.6) | 13 (0.6) |
| Missing | 3 (0.2) | 4 (0.4) | 7 (0.3) |
Abbreviations: AD, Alzheimer’s disease; ADAS-cog, Alzheimer’s Disease Assessment Scale—Cognitive subscale; APOE, apolipoprotein E; CDR-SB, Clinical Dementia Rating scale sum of boxes; DAD, Disability Assessment Scale for Dementia; DS, Dependence Scale; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory; RUD-Lite v2.4, Resource Utilization in Dementia version 2.4; SD, standard deviation.