Table 1. Demographics and Baseline Characteristics (ITT Analysis Set)a.
| Characteristic | No. (%) | ||
|---|---|---|---|
| Placebo (n = 185) | Atabecestat | ||
| 5 mg (n = 189) | 25 mg (n = 183) | ||
| Age, mean (SD), y | 70.2 (5.81) | 70.6 (5.26) | 70.5 (5.62) |
| Age category, y | |||
| <65 | 33 (17.8) | 23 (12.2) | 30 (16.4) |
| 65-74 | 106 (57.3) | 121 (64.0) | 111 (60.7) |
| ≥75 | 46 (24.9) | 45 (23.8) | 42 (23.0) |
| Women | 108 (58.4) | 116 (61.4) | 117 (63.9) |
| Race | |||
| White | 167 (90.3) | 173 (91.5) | 168 (91.8) |
| Black or African American | 2 (1.1) | 1 (0.5) | 2 (1.1) |
| Asian | 12 (6.5) | 11 (5.8) | 11 (6.0) |
| American Indian or Alaska native | 0 | 1 (0.5) | 0 |
| Other | 4 (2.2) | 3 (1.6) | 2 (1.1) |
| Ethnicityb | |||
| Hispanic or Latino | 8 (4.3) | 6 (3.2) | 7 (3.8) |
| Not Hispanic or Latino | 176 (95.1) | 183 (96.8) | 176 (96.2) |
| Education | |||
| Less than high school | 16 (8.7) | 10 (5.3) | 14 (7.7) |
| High school and higher | 169 (91.4) | 179 (94.7) | 169 (92.3) |
| BMI | |||
| Mean (SD) | 26.9 (4.51) | 26.2 (4.27) | 26.7 (4.88) |
| Category | |||
| Normal, 18.5 to <25 | 70 (38.5) | 72 (38.5) | 75 (41.9) |
| Overweight, 25 to <30 | 70 (38.5) | 80 (42.8) | 67 (37.4) |
| Obese, ≥30 | 42 (23.1) | 32 (17.1) | 36 (20.1) |
| MMSE score, mean (SD) | 28.2 (1.81) | 28.3 (1.65) | 28.2 (1.65) |
| Scores | |||
| PACC | |||
| No. | 80 | 75 | 66 |
| Mean (SD) | −0.26 (3.00) | 0.16 (2.690) | −0.01 (2.840) |
| RBANS total | |||
| No. | 119 | 117 | 110 |
| Mean (SD) | 99.9 (13.69) | 101.1 (12.09) | 100.1 (13.60) |
| APOE ε4 carrier | 102 (55.1) | 108 (57.1) | 103 (56.3) |
| Adjusted baseline hippocampal volume, mean (SD) | 5634.0 (577.62) | 5631.7 (599.96) | 5666.9 (675.42) |
| CFI total score | |||
| Participant | |||
| No. | 178 | 184 | 181 |
| Mean (SD) | 1.9 (2.06) | 1.9 (2.01) | 1.7 (1.89) |
| Study partner | |||
| No. | 176 | 182 | 180 |
| Mean (SD) | 1.3 (1.90) | 1.1 (1.56) | 1.4 (1.98) |
Abbreviations: APOE ε4, apolipoprotein E ε4 allele; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CFI, cognitive function index; ITT, intention-to-treat; MMSE, Mini-Mental State Examination; PACC, Preclinical Alzheimer Cognitive Composite; RBANS, Repeatable Battery for the Assessment of Neuropsychological Status.
One hundred forty-three centers; in the United States (61 centers), Japan (13 centers), Spain (12 centers), Australia (9 centers), Germany (9 centers), United Kingdom (8 centers), Italy (7 centers), Belgium (6 centers), Denmark (4 centers), the Netherlands (4 centers), Mexico (3 centers), Canada (2 centers), Finland (4 centers), and Sweden (1 center).
One patient from the placebo group was of unknown ethnicity.