Week 12 | Week 24 | |||||
---|---|---|---|---|---|---|
Treatment arm | Masitinib treatment | Placebo | P value | Masitinib treatment | Placebo | P value |
ADAS-Coga | ||||||
Evaluable patients | 17 | 6 | 16 | 6 | ||
Improvementb | 7 (41%) | 1 (17%) | 0.369 | 6 (38%) | 1 (17%) | 0.616 |
Worseningb | 1 (6%) | 3 (50%) | 0.040 | 1 (6%) | 3 (50%) | 0.046 |
Mean absolute change | -2.6 ± 3.6 | 4.2 ± 6.6 | 0.016 | -1.8 ± 6.1 | 5.8 ± 7.9 | 0.030 |
ADCS-ADLc | ||||||
Evaluable patients | 16 | 6 | 15 | 6 | ||
Improvementd | 8 (50%) | 0 (0%) | 0.051 | 9 (60%) | 1 (17%) | 0.149 |
Worseningd | 5 (31%) | 3 (50%) | 0.624 | 4 (27%) | 3 (50%) | 0.354 |
Mean absolute change | 6.9 ± 10.9 | -4.2 ± 6.9 | 0.035 | 5.5 ± 15.8 | -1.8 ± 7.0 | 0.128 |
MMSEc | ||||||
Evaluable patients | 17 | 7 | 16 | 7 | ||
Mean absolute change | 0.1 ± 2.5 | -2.1 ± 2.5 | 0.047 | -0.1 ± 4.3 | -3.3 ± 3.3 | 0.031 |
CDR responsee | ||||||
Evaluable patients | 17 | 7 | 0.778* | 16 | 7 | 0.293* |
Response | 2 (12%) | 1 (14%) | 3 (19%) | 1 (14%) | ||
No change | 14 (82%) | 5 (71%) | 12 (75%) | 4 (57%) | ||
Worsening | 1 (6%) | 1 (14%) | 1 (6%) | 2 (29%) | ||
CIBIC-Plus | ||||||
Evaluable patients | 17 | 6 | 0.292* | 16 | 6 | 0.474* |
Response (1 to 3) | 1 (6%) | 1 (17%) | 2 (13%) | 0 | ||
No change (4) | 14 (82%) | 2 (33%) | 12 (75%) | 5 (83%) | ||
Worsening (5 to 7) | 2 (12%) | 3 (50%) | 2 (13%) | 1 (17%) |