Table 1. Baseline Demographic and Clinical Characteristics (Randomized Sample).
| Characteristic | Placebo (n = 117), No. (%)a | Brexpiprazole, No. (%)a | ||
|---|---|---|---|---|
| 2 or 3 mg (n = 228) | 2-mg Subgroup (n = 75) | 3-mg Subgroup (n = 153) | ||
| Demographic | ||||
| Age, mean (SD), y | 73.0 (7.0) | 74.5 (7.7) | 74.3 (7.3) | 74.6 (8.0) |
| Age group, y | ||||
| <65 | 13 (11.1) | 24 (10.5) | 8 (10.7) | 16 (10.5) |
| ≥65 to <75 | 54 (46.2) | 83 (36.4) | 29 (38.7) | 54 (35.3) |
| ≥75 | 50 (42.7) | 121 (53.1) | 38 (50.7) | 83 (54.2) |
| Weight, mean (SD), kg | 71.3 (13.8) | 70.5 (15.5) | 70.9 (15.5) | 70.2 (15.5) |
| BMI, mean (SD)b | 26.6 (4.8) | 26.3 (4.7) | 26.6 (4.7) | 26.1 (4.7) |
| Sex | ||||
| Female | 60 (51.3) | 135 (59.2) | 43 (57.3) | 92 (60.1) |
| Male | 57 (48.7) | 93 (40.8) | 32 (42.7) | 61 (39.9) |
| Race | ||||
| Asian | 1 (0.9) | 3 (1.3) | 0 | 3 (2.0) |
| Black or African American | 1 (0.9) | 11 (4.8) | 5 (6.7) | 6 (3.9) |
| White | 115 (98.3) | 214 (93.9) | 70 (93.3) | 144 (94.1) |
| Ethnicity | ||||
| Hispanic or Latino | 37 (31.6) | 71 (31.1) | 25 (33.3) | 46 (30.1) |
| Not Hispanic or Latino | 80 (68.4) | 157 (68.9) | 50 (66.7) | 107 (69.9) |
| Living situation | ||||
| Care facility | 54 (46.2) | 96 (42.1) | 32 (42.7) | 64 (41.8) |
| Community-based setting | 63 (53.8) | 132 (57.9) | 43 (57.3) | 89 (58.2) |
| Clinical | ||||
| Time since Alzheimer disease diagnosis, mean (SD), mo | 34.1 (31.4) | 36.7 (36.9) | 34.5 (38.9) | 37.8 (36.0) |
| Time since onset of current agitation episode requiring pharmacotherapy, mean (SD), mo | 8.9 (10.7) | 10.0 (14.8) | 9.0 (14.4) | 10.5 (15.0) |
| CMAI total score, mean (SD) | 79.4 (17.6) | 80.4 (16.7) | 78.6 (15.5) | 81.2 (17.2) |
| CGI-S score as related to agitation, mean (SD) | 4.7 (0.7) | 4.7 (0.7) | 4.6 (0.7) | 4.7 (0.6) |
| NPI-NH total score, mean (SD) | 36.5 (17.0)c | 37.5 (17.7)d | 37.9 (17.1)e | 37.3 (18.1)f |
| NPI-NH Agitation/Aggression domain score, mean (SD) | 7.5 (2.1) | 7.7 (2.2) | 7.9 (2.4) | 7.6 (2.0) |
| Psychosis (≥4 NPI delusion/hallucination symptoms) | 21 (17.9) | 44 (19.3) | 14 (18.7) | 30 (19.6) |
| MMSE score, mean (SD) | 15.5 (3.9) | 15.6 (3.7) | 15.8 (3.2) | 15.5 (3.9) |
| MMSE score category | ||||
| Mild (>18) | 28 (23.9) | 53 (23.2) | 16 (21.3) | 37 (24.2) |
| Moderate (13-18) | 66 (56.4) | 127 (55.7) | 48 (64.0) | 79 (51.6) |
| Severe (≤12) | 23 (19.7) | 48 (21.1) | 11 (14.7) | 37 (24.2) |
Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression–Severity of illness; CMAI, Cohen-Mansfield Agitation Inventory; NPI, Neuropsychiatric Inventory; NPI-NH, Neuropsychiatric Inventory–Nursing Home version; MMSE, Mini-Mental State Examination.
a
Values are No. (%) unless otherwise described as mean (SD).
b
Calculated as weight in kilograms divided by height in meters squared.
c
n = 116.
d
n = 226.
e
n = 74.
f
n = 152.