| |
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%)
| |
- Summary of efficacy outcomes at weeks 12 and 24 according to observed cases dataset analysis on the intent-to-treat population. Data presented as mean ± standard deviation, or number (%). Week 12 data for closed study centre (n = 8 patients) was imputed using last observation carried forward for week 24. ADAS-Cog, Alzheimer's Disease Assessment Scale - cognitive subscale; ADCS-ADL, Alzheimer's Disease Cooperative Study Activities of Daily Living; CDR, Clinical Dementia Rating; CIBIC-plus, Clinician's Interview-Based Impression of Change-plus caregiver input; MMSE, Mini-Mental State Examination. aNegative change reflects improvement. bADAS-Cog response criteria were improvement (decrease ≥4), worsening (increase ≥4). cPositive change reflects improvement. dADCS-ADL response criteria were improvement (increase ≥3), worsening (decrease <0). eCDR response criteria were positive response (decrease > 0), worsening (increase > 0). *Global P value.
