|
Groups
|
n
|
Baseline (week 0) score
|
Week 12 (LOCF) change
| |
---|
Mean ± SD
|
Mean ± SD
|
P-
value
b
|
---|
MMSEc
| Placebo | 44 | 20.3 ± 4.2 | 0.6 ± 3.0 | |
5 mg | 45d
| 20.6 ± 4.1 | 1.4 ± 3.4 | 0.232 |
10 mg | 49 | 20.3 ± 4.8 | 2.2 ± 2.9 | 0.016 |
NPI-2e
| Placebo | 44 | 6.9 ± 4.5 | −2.0 ± 4.2 | |
5 mg | 45 | 6.9 ± 4.5 | −1.7 ± 4.3 | 0.661 |
10 mg | 49 | 7.3 ± 4.7 | −2.9 ± 4.7 | 0.391 |
-
aFAS, Full analysis set; LOCF, Last observation carried forward; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory. bAnalysis of covariance with treatment groups as factors and baseline values as covariates. Significance was defined as P < 0.05. cPositive value of the MMSE change indicates an improvement in cognitive function. dThe number of patients at week 12 (LOCF) was 43. eA negative value of the NPI-2 change indicates an improvement in behavioral and neuropsychiatric symptoms.