Table 3.
MMRM results for selected secondary and exploratory endpoints at week 12 (visit 5)
| Endpoint | Treatment group | n | LS mean (SE) | 80% CI | Difference (SE) | 80% CI for difference | Two-sided P value |
|---|---|---|---|---|---|---|---|
| NPI total | SAM-760 | 78 | −3.99 (1.24) | −5.59, −2.40 | 2.19 (1.71) | −0.01, 4.40 | 0.20 |
| Placebo | 87 | −6.18 (1.18) | −7.70, −4.67 | ||||
| ADAS-cog11 | SAM-760 | 78 | 0.26 (0.55) | −0.44, 0.97 | 0.65 (0.76) | −0.32, 1.62 | 0.39 |
| Placebo | 87 | −0.39 (0.52) | −1.05, 0.28 | ||||
| ADCS-ADL | SAM-760 | 65 | −0.69 (0.82) | −1.75, 0.37 | 0.82 (1.13) | −0.64, 2.28 | 0.47 |
| Placebo | 72 | −1.51 (0.78) | −2.51, −0.50 | ||||
| CSDD | SAM-760 | 79 | −1.41 (0.34) | −1.85, −0.97 | − 0.59 (0.47) | −1.19, 0.02 | 0.22 |
| Placebo | 86 | −0.82 (0.32) | −1.24, −0.41 | ||||
| CGI-I | SAM–760 | 80 | 3.83 (0.12) | 3.68, 3.98 | −0.03 (0.16) | −0.23, 0.18 | 0.87 |
| Placebo | 86 | 3.86 (0.11) | 3.71, 4.00 | ||||
| MMSE | SAM-760 | 80 | 0.43 (0.29) | 0.05, 0.80 | −0.38 (0.40) | −0.90, 0.13 | 0.34 |
| Placebo | 88 | 0.81 (0.28) | 0.45, 1.16 |
ADAS-cog11 Alzheimer’s Disease Assessment Scale-cognitive subscale, ADCS-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living, CGI-I Clinician’s Global Impression of Improvement, CSDD Cornell Scale for Depression in Dementia, MMRM mixed model repeated measures, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory