Table 2.
Baseline demographic and clinical characteristics
| Patients included in the safety analysis | Patients included in the efficacy analysis | |
|---|---|---|
| Characteristic | N=642 | N=554 |
| Age (years), mean (SD) | 79.10 (7.20) | 78.99 (7.31) |
| <65, n (%) | 21 (3.27%) | 19 (3.43%) |
| 65–74, n (%) | 126 (19.63%) | 113 (20.40%) |
| ≥75, n (%) | 495 (77.10%) | 422 (76.17%) |
| Gender, n (%) | ||
| Female | 421 (65.58%) | 369 (66.61%) |
| Male | 221 (34.42%) | 185 (33.39%) |
| Disease duration (year), mean (SD) | 0.73 (1.48) | 0.75 (1.41) |
| Hospitalization at study entry, n (%) | ||
| No | 566 (88.16%) | 486 (87.73%) |
| Yes | 32 (4.98%) | 26 (4.69%) |
| Repeated entry and leave | 44 (6.85%) | 42 (7.58%) |
| Dose (mg/day), mean (SD) | 15.01 (4.76) | 15.52 (4.48) |
| Duration of exposure (days), mean (SD) | 343.44 (202.30) | 371.74 (185.63) |
| Pretreatment antidementia drugs, n (%) | ||
| No | 495 (77.10%) | 425 (76.72%) |
| Yes | 147 (22.90%) | 129 (23.29%) |
| Polypharmacy, n (%) (combined with memantine) | 65 (10.12%) | 60 (10.83%) |
| Stages of Alzheimer’s disease (FAST stage) | ||
| No cognitive decline, n (%) | 0 (0.00%) | 0 (0.00%) |
| Very mild cognitive decline, n (%) | 21 (3.27%) | 20 (3.61%) |
| Mild cognitive decline, n (%) | 251 (39.10%) | 209 (37.73%) |
| Moderate cognitive decline, n (%) | 306 (47.66%) | 271 (48.92%) |
| Moderately severe cognitive decline, n (%) | 53 (8.26%) | 46 (8.30%) |
| Severe cognitive decline, n (%) | 2 (0.31%) | 2 (0.36%) |
| Very severe cognitive decline, n (%) | 1 (0.16%) | 1 (0.18%) |
| MMSE, mean (SD) | – | 18.95 (5.04) |
Abbreviations: FAST, functional assessment staging; MMSE, mini mental state examination; SD, standard deviation.