Masitinib 4.5 mg/kg/day parallel group | Titrated masitinib 6.0 mg/kg/day parallel group | ||||
---|---|---|---|---|---|
M4.5 (n=182) | PBO (n=176) | tM6.0 (n=182) | tPBO (n=91) | ||
Gender | Female [n (%)] | 114 (62.6%) | 98 (55.7%) | 118 (63.4%) | 57 (62.6%) |
Age (years) | Mean (±SD) | 71.9 (±8.3) | 71.7 (±8.2) | 71.9 (±8.3) | 71.2 (±8.1) |
Median | 73.0 | 73.0 | 72.0 | 72.0 | |
Range (min–max) | 50.0–86.0 | 50.0–88.0 | 50.0–88.0 | 51.0–87.0 | |
>=50–<60 [n (%)] | 19 (10.4%) | 17 (9.4%) | 14 (7.5%) | 10 (11.0%) | |
>=60–<70 [n (%)] | 44 (24.0%) | 52 (28.9%) | 54 (29.0%) | 26 (28.6%) | |
>=70–<80 [n (%)] | 82 (44.8%) | 76 (42.2%) | 78 (41.9%) | 41 (45.1%) | |
≥ 80 [n (%)] | 38 (20.8%) | 35 (19.4%) | 40 (21.5%) | 14 (15.4%) | |
MMSE | Mean (±SD) | 18.8 (±3.7) | 18.6 (±3.8) | 18.8 (±3.6) | 18.7 (±3.7) |
Median | 19.0 | 19.0 | 19.0 | 19.0 | |
MMSE [12–20] [n (%)] | 119 (65.4%) | 115 (65.3%) | 123 (66.1%) | 57 (62.6%) | |
MMSE [21–25] [n (%)] | 63 (34.6%) | 61 (34.7%) | 63 (33.9%) | 34 (37.4%) | |
ADCS-ADL | Mean (±SD) | 51.8 (±15.1) | 51.4 (±15.0) | 52.4 (±14.8) | 53.2 (±13.7) |
Median | 55.0 | 53.5 | 54.0 | 57.0 | |
Range (min–max) | 13.0–78.0 | 4.0–77.0 | 9.0–78.0 | 18.0–77.0 | |
ADAS-cog | Mean (±SD) | 26.1 (±10.1) | 25.9 (±9.7) | 24.9 (±10.1) | 26.2 (±10.6) |
Median | 25.5 | 24.8 | 24.3 | 24.3 | |
Range (min–max) | 7.2–54.3 | 9.2–53.0 | 4.7–57.3 | 6.8–51.7 | |
CDR | Mean (±SD) | 1.3 (±0.6) | 1.2 (±0.8) | 1.2 (±0.6) | 1.1 (±0.6) |
Median | 1 | 1 | 1 | 1 | |
Range (min–max) | 0.5–3 | 0.5–3 | 0–3 | 0.5–2 |