Table 1. Baseline Demographic Characteristics.
| Characteristic | No. (%) | ||||
|---|---|---|---|---|---|
| Total | Ineligible for study participationa | Treatment cohort 1 (ACI-24, 300 μg) | Treatment cohort 2 (ACI-24, 1000 μg) | Placebo cohorts 1 and 2 | |
| Total participants, No. | 20 | 4 | 6 | 6 | 4 |
| Age at signing of informed consent, y | |||||
| Mean (SD) | 32.9 (4.1) | 34.0 (2.6) | 33.5 (4.6) | 31.5 (4.9) | 33.0 (4.2) |
| Median (range) | 33.5 (25.0-41.0) | 34.0 (31.0-37.0) | 32.5 (28.0-41.0) | 33.0 (25.0-36.0) | 33.0 (28.0-38.0) |
| Sex | |||||
| Female | 11 (55.0) | 2 (50.0) | 2 (33.3) | 4 (66.7) | 3 (75.0) |
| Male | 9 (45.0) | 2 (50.0) | 4 (66.7) | 2 (33.3) | 1 (25.0) |
| Race | |||||
| Racial minority groupsb | 0 | 0 | 0 | 0 | 0 |
| White | 20 (100) | 4 (100) | 6 (100) | 6 (100) | 4 (100) |
| Ethnicity | |||||
| Hispanic or Latino | 1 (5.0) | 0 | 0 | 1 (16.7) | 0 |
| Non-Hispanic or non-Latino | 19 (95.0) | 4 (100) | 6 (100) | 5 (83.3) | 4 (100) |
| APOE genotype | |||||
| ε3/ε3 | 8 (40.0) | 0 | 3 (50.0) | 3 (50.0) | 2 (50.0) |
| ε2/ε3 | 2 (10.0) | 0 | 1 (16.7) | 1 (16.7) | 0 |
| ε3/ε4 | 2 (10.0) | 0 | 1 (16.7) | 0 | 1 (25.0) |
| Not reported | 8 (40.0) | 4 (100) | 1 (16.7) | 2 (33.3) | 1 (25.0) |
| BMI at screening | |||||
| Mean (SD) | 40.2 (10.1) | 42.8 (11.6) | 37.0 (9.9) | 39.9 (9.4) | 43.1 (12.7) |
| Median (range) | 39.4 (24.3-58.3) | 41.2 (30.5-58.3) | 37.3 (24.3-52.0) | 35.1 (31.9-53.4) | 47.4 (25.1-52.4) |
| KBIT-2 IQ composite | |||||
| Mean (SD) | 47.8 (10.4) | 52.8 (18.9) | 44.2 (5.5) | 49.2 (9.5) | 46.0 (8.0) |
| Median (range) | 42.0 (40.0-80.0) | 45.5 (40.0-80.0) | 42.0 (40.0-54.0) | 48.5 (40.0-60.0) | 43.5 (40.0-57.0) |
Abbreviations: APOE, apolipoprotein E; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); KBIT-2, Kaufman Brief Intelligence Test, Second Edition.
a
Ineligibility determined by initial screening results.
b
Racial minority groups include American Indian or Alaska Native, Asian, and Black or African American.