Table 1.
Characteristics of the Participants at Baseline (Modified Intention-to-Treat Population).*
| Characteristic | Solanezumab (N = 564) | Placebo (N = 583) |
|---|---|---|
|
| ||
| Age — yr | 72.0±4.7 | 71.9±5.0 |
| Female sex — no. (%) | 329 (58.3) | 352 (60.4) |
| Education — yr | 16.6±2.7 | 16.6±2.9 |
| Race — no. (%)† | ||
| White | 531 (94.1) | 549 (94.2) |
| Black | 12 (2.1) | 15 (2.6) |
| Asian | 11 (2.0) | 13 (2.2) |
| Other or missing | 10 (1.8) | 6 (1.0) |
| Ethnic group — no. (%)† | ||
| Not Hispanic or Latino | 542 (96.1) | 560 (96.1) |
| Hispanic or Latino | 16 (2.8) | 18 (3.1) |
| Unknown or not reported | 6 (1.1) | 5 (0.9) |
| Family history of dementia: parent or sibling — no. (%) | 411 (72.9) | 449 (77.0) |
| ApoE genotype — no. (%) | ||
| ε2/ε2 | 1 (02) | 0 |
| ε2/ε3 | 28 (5.0) | 33 (5.7) |
| ε2/ε4 | 13 (2.3) | 22 (3.8) |
| ε3/ε3 | 202 (35.8) | 208 (35.7) |
| ε3/ε4 | 273 (48.4) | 273 (46.8) |
| ε4/ε4 | 47 (8.3) | 47 (8.1) |
| ApoE ε4 carrier | 333 (59.0) | 342 (58.7) |
| Amyloid burden on 18F-florbetapir PET | ||
| SUVR | 1.3±0.2 | 1.3±0.2 |
| Centiloids | 66.2±33.5 | 65.9±32.1 |
| PACC score‡ | 0.0±2.8 | 0.0±2.6 |
| Wechsler Memory Scale LMDR score§ | 12.6±3.8 | 12.7±3.5 |
| MMSE score¶ | 28.8±1.3 | 28.8±1.2 |
| CFI combined score‖ | 4.0±3.6 | 3.6±3.3 |
| ADL partner score** | 43.4±2.7 | 43.5±2.6 |
| CDR-SB score†† | 0.1±0.2 | 0.0±0.2 |
Plus–minus values are means ±SD. The modified intention-to-treat population included randomly assigned participants who received at least one dose of solanezumab or placebo and underwent assessment for the primary end point. Percentages may not total 100 because of rounding. More details on baseline characteristics are provided in Table S1. ApoE denotes apolipoprotein E, PET positron-emission tomography, and SUVR standardized uptake value ratio.
Race and ethnic group were reported by the participant.
The Preclinical Alzheimer Cognitive Composite (PACC) score is the sum of four z scores, with higher scores indicating better cognitive performance.
Wechsler Memory Scale Logical Memory Delayed Recall (LMDR) scores range from 0 to 25, with lower scores indicating fewer details recalled.
Scores on the Mini–Mental State Examination (MMSE) range from 0 to 30, with lower scores indicating poorer cognition.
Scores on the Cognitive Function Index (CFI) range from 0 to 15, with higher scores indicating greater subjective concerns about cognitive function. Responses by the participant and participant’s partner were added together (range, 0 to 30).
Scores on the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADL) Prevention Questionnaire, as assessed by the participant’s partner, range from 0 to 45, with higher scores indicating more difficulty in performing activities of daily living.
Scores on the Clinical Dementia Rating (CDR)–Sum of Boxes (CDR-SB) range from 0 to 18, with higher scores indicating greater impairment in global functioning.