Table 1. Demographics and clinical baseline characteristics of the patients (ITT population, n = 198).
| Variable | Group 1 (n = 136) | Group 2 (n = 62) | p-value |
|---|---|---|---|
| Age, years | 73.35±8.08 | 75.61±6.34 | 0.0851 |
| Gender | |||
| Male | 38 (27.9%) | 20 (32.3%) | 0.6142 |
| Female | 98 (72.1%) | 42 (67.7%) | |
| Education, years | 6.80±4.36 | 6.63±5.26 | 0.5301 |
| Concurrent medical conditions | |||
| Hypertension | 57 (41.9%) | 34 (54.8%) | 0.0912 |
| Diabetes mellitus | 34 (25.0%) | 20 (32.3%) | 0.2882 |
| Hyperlipidemia | 23 (16.9%) | 9 (14.5%) | 0.6712 |
| Heart Disease | 15 (11.0%) | 10 (16.1%) | 0.3162 |
| Depression | 7 (5.1%) | 4 (6.5%) | 0.7433 |
| Other disease | 42 (30.9%) | 22 (35.5%) | 0.5212 |
| ADAS-Cog | 22.73±7.84 | 23.40±7.27 | 0.4781 |
| MMSE | 19.63±4.03 | 19.95±4.10 | 0.5501 |
| FAB | 10.15±3.47 | 10.08±3.44 | 0.9971 |
| ADCS-ADL | 59.32±12.39 | 59.24±11.97 | 0.8661 |
| CGA-NPI | 10.51±12.57 | 8.89±11.48 | 0.2021 |
| CDR-SB | 3.89±2.21 | 4.17±2.26 | 0.3081 |
| Mini-Zarit (caregiver burden) | 18.93±14.83 | 17.79±13.36 | 0.6991 |
1P values were derived from the Mann-Whitney U test;
2P values were derived from the chi-square test;
3P values were derived from Fisher’s exact test. The Shapiro-Wilk test was used to test for normality assumption.
Values are means ± standard deviations. ITT = intent to treat; LOCF = Last Observation Carried Forward; ADAS-Cog = Alzheimer’s Disease Assessment Scale-Cognitive subscale; MMSE = Mini-Mental State Examination; FAB = Frontal Assessment Battery; CGA-NPI = Caregiver-Administered Neuropsychiatric Inventory; ADSC-ADL = Alzheimer’s Disease Cooperative Study-Activities of Daily Living; CDR-SB = Clinical Dementia Rating Scale-Sum of Boxes.