Table 1.
Characteristics of the Participants at Baseline.*
| Characteristic | GRADUATE I | GRADUATE II | ||
|---|---|---|---|---|
| Gantenerumab (N = 499) | Placebo (N = 485) | Gantenerumab (N = 498) | Placebo (N = 477) | |
| Age — yr | 71.1±7.9 | 72.1±7.8 | 71.6±7.8 | 71.8±7.4 |
| Female sex — no. (%) | 290 (58.1) | 255 (52.6) | 288 (57.8) | 285 (59.7) |
| Use of medication for Alzheimer’s disease symptoms — no. (%) | 312 (62.5) | 295 (60.8) | 331 (66.5) | 315 (66.0) |
| Clinical stage — no. (%) | ||||
| Mild cognitive impairment due to Alzheimer’s disease | 275 (55.1) | 263 (54.2) | 269 (54.0) | 266 (55.8) |
| Mild dementia due to Alzheimer’s disease | 224 (44.9) | 222 (45.8) | 229 (46.0) | 211 (44.2) |
| CDR-GS — no. (%)† | ||||
| 0.5 | 344 (68.9) | 359 (74.0) | 344 (69.2) | 360 (75.5) |
| 1 | 149 (29.9) | 123 (25.4) | 150 (30.2) | 116 (24.3) |
| 2 | 6 (1.2) | 3 (0.6) | 3 (0.6) | 1 (0.2) |
| CDR-SB score‡ | 3.71±1.67 | 3.71±1.57 | 3.67±1.61 | 3.52±1.54 |
| ADAS-Cog13 score§ | 28.1±7.1 | 28.1±6.8 | 28.1±6.9 | 28.2±7.0 |
| ADCS-ADL total score¶ | 67.9±7.2 | 68.2±6.8 | 68.3±7.3 | 68.9±7.2 |
| FAQ score‖ | 8.0±5.9 | 7.8±5.7 | 7.7±5.8 | 6.8±5.3 |
| MMSE score** | 23.5±3.3 | 23.6±3.0 | 23.6±3.1 | 23.8±3.2 |
| APOE ε4 genotype — no. (%) | ||||
| No ε4 allele | 173 (34.7) | 157 (32.4) | 165 (33.1) | 156 (32.7) |
| One or two ε4 alleles | 326 (65.3) | 328 (67.6) | 333 (66.9) | 321 (67.3) |
| One ε4 allele | 235 (47.1) | 241 (49.7) | 242 (48.6) | 254 (53.2) |
| Two ε4 alleles | 91 (18.2) | 87 (17.9) | 91 (18.3) | 67 (14.0) |
| Amyloid burden on PET — centiloids†† | 94.44±26.48 | 96.07±31.47 | 95.62±30.76 | 90.70±30.80 |
Plus-minus values are means ±SD. Percentages may not total 100 because of rounding. Data for baseline characteristics are shown for participants who received at least one dose of gantenerumab or placebo. Data for additional baseline characteristics, including race, ethnic group, and education level, are provided in Table S2.
The Clinical Dementia Rating scale-Global Score (CDR-GS) is derived from an algorithm with six domains; possible scores are 0, 0.5, 1, 2, or 3, with higher scores indicating greater cognitive impairment. A CDR-GS of 0.5 or 1 at screening was a criterion for eligibility. In the gantenerumab group of the GRADUATE II trial, CDR-GS data were available for 497 participants.
On the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB), scores range from 0 to 18, with higher scores indicating greater cognitive impairment.
On the 13-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog 13), scores range from 0 to 85, with higher scores indicating greater cognitive impairment.
On the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), total scores range from 0 to 78, with lower scores indicating greater functional impairment.
On the Functional Activities Questionnaire (FAQ), scores range from 0 to 30, with higher scores indicating greater functional impairment.
On the Mini-Mental State Examination (MMSE), scores range from 0 to 30, with lower scores indicating greater impairment.
Data for amyloid burden on positron-emission tomography (PET) are shown for participants enrolled in the amyloid PET substudy: 123 participants in the GRADUATE I trial (65 in the gantenerumab group and 58 in the placebo group) and 114 participants in GRADUATE II trial (58 in the gantenerumab group and 56 in the placebo group).