Table 2.
Secondary Efficacy Outcomes at End Point (ITT, Last Observation Carried Forward)
| Least Squares Mean Change From Baseline Scores (SE) |
Difference in Least Squares Mean (95% CI) |
|||
|---|---|---|---|---|
| Placebo | Donepezil | P | ||
| Cognitive assessments | ||||
| ADAS-cog* | −0.33 (0.29) | −1.04(0.21) | −0.707 (−1.40, −0.02) | 0.0464 |
| MMSE† | 0.18 (0.18) | 0.65 (0.13) | 0.472 (0.05, 0.89) | 0.0301 |
| Executive function tests | ||||
| EXIT25* | −0.70 (0.27) | −0.86 (0.20) | −0.160 (−0.80, 0.48) | 0.6255 |
| CLOX-1† | 0.17 (0.16) | 0.42 (0.12) | 0.243 (−0.13, 0.62) | 0.2104 |
| CLOX-2† | 0.07 (0.13) | −0.06 (0.09) | −0.131 (−0.44, 0.18) | 0.4090 |
| NCT* | −0.09 (0.05) | −0.22 (0.04) | 0.131 (−0.26, −0.01) | 0.0396 |
| Maze* | 0.45 (0.11) | 0.29 (0.08) | 0.157 (−0.41, 0.10) | 0.2327 |
| Daily functioning | ||||
| DAD† | −0.24 (0.77) | 1.53 (0.56) | 1.768 (−0.05, 3.59) | 0.0591 |
| Global assessment | ||||
| CDR-SB* | 0.03 (0.10) | 0.05 (0.07) | 0.020 (−0.20, 0.24) | 0.8654 |
MMSE indicates Mini Mental State Examination; and CDR-SB, Clinical Dementia Rating-Sum of the Boxes.
*
Negative change indicates improvement.
†
Positive change indicates improvement.