Table 3.
Demographics of patients in placebo groups from eight placebo-controlled randomized trials targeting AD
| AD severity |
Mild to moderate |
Severe |
||||||
|---|---|---|---|---|---|---|---|---|
| Trial name | EIS-161 | JPN-3 | MA3301 | JPN-5 | D1301 | IE2101 | EIS-231 | IE3501 |
| Total number of patients∗ | 129 | 136 | 180 | 194 | 268 | 107 | 102 | 208 |
| Gender, N (%) | ||||||||
| Female | 84 (65.1) | 96 (70.6) | 111 (61.7) | 135 (59.6) | 182 (67.9) | 76 (71.0) | 84 (82.4) | 135 (64.9) |
| Male | 45 | 40 | 69 | 59 | 86 | 31 | 18 | 73 |
| Age (years), Mean (SD) | 69.5 (8.88) | 74.6 (8.46) | 72.5 (9.06) | 75.6 (7.62) | - | 73.6 (8.87) | 79.5 (7.25) | 74.9 (8.44) |
| Disease duration (months), Mean (SD) | 40.78 (22.13) | 16.04 (21.91) | 16.73 (18.45) | 39.63 (24.94) | - | 54.84 (32.26) | 67.38 (41.84) | 54.35 (30.32) |
| Age at onset (years) | ||||||||
| Number | 128 | 136 | 180 | 194 | - | 107 | 96 | 208 |
| Mean (SD) | 65.7 (8.83) | 72.7 (8.71) | 71.1 (9.13) | 71.8 (7.97) | 69.0 (9.28) | 73.8 (7.86) | 70.4 (8.81) | |
| MMSE, N (%) | - | |||||||
| ≥18 | 54 (41.9) | 51 (37.5) | 94 (52.2) | 76 (39.2) | 132 (49.3) | 0 (0.0) | 0 (0.0) | |
| <18 | 75 (58.1) | 85 (62.5) | 85 (47.2) | 118 (60.8) | 136 (50.7) | 107 (100.0) | 102 (100.0) | |
| Unknown | 0 (0.0) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Caregiver, N (%) | ||||||||
| Presence | 129 (100.0) | - | - | - | 263 (98.1) | 107 (100.0) | 102 (100.0) | 208 (100.0) |
| Absence | 0 (0.0) | 5 (1.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
| Caregivers' relationship with patients, N (%) | ||||||||
| Wife | 42 (32.6) | - | - | - | - | 26 (24.3) | 13 (12.7) | 63 (30.3) |
| Husband | 45 (34.9) | 24 (22.4) | 13 (12.7) | 60 (28.8) | ||||
| Child | 25 (19.4) | 48 (44.9) | 31 (30.4) | 73 (35.1) | ||||
| Others | 17 (13.2) | 9 (8.4) | 45 (44.1) | 12 (5.8) | ||||
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||||
| History of rehabilitation, N (%) | ||||||||
| Absence | 123 (95.3) | 97 (71.3) | 141 (78.3) | 180 (92.8) | - | 50 (46.7) | 81 (79.4) | 89 (42.8) |
| Presence | 6 (4.7) | 39 (28.7) | 39 (21.7) | 14 (7.2) | 57 (53.3) | 21 (20.6) | 119 (57.2) | |
| AChEIs as prior treatment, N (%) | ||||||||
| Presence | 0 (0.0) | 66 (48.5) | 97 (53.9) | 106 (54.6) | - | 45 (42.1) | 0 (0.0) | 141 (67.8) |
| Absence | 129 (100.0) | 70 (51.5) | 83 (46.1) | 88 (45.4) | 62 (57.9) | 102 (100.0) | 67 (32.2) | |
Abbreviations: AD, Alzheimer's disease; -, absent data; MMSE, Mini-Mental State Examination; AChEIs, acetylcholinesterase inhibitors; SD, standard deviation.
∗
Patient numbers of each category is the same as the total number of patients in the third column unless otherwise indicated.