Table 3.
Change from baseline in ADAS-Cog total scores at week 24 – MMRM1 (ITT population)
| Subject group | Treatment group | Number2 | LSM | SE | Treatment comparison |
||
|---|---|---|---|---|---|---|---|
| difference3 | 95% CI | P | |||||
| APOE ε4 negative | placebo | 63 | 1.6 | 0.78 | _ | _ | _ |
| 2 mg RSG XR | 69 | −0.2 | 0.67 | −1.8 | −3.8,0.2 | 0.074 | |
| 8 mg RSG XR | 65 | 0.6 | 0.67 | −1.0 | −3.0, 1.0 | 0.338 | |
| 10 mg donepezil | 28 | 0.9 | 1.16 | −0.7 | −3.5,2.1 | 0.6024 | |
| All except ε4/ε4 | placebo | 117 | 1.5 | 0.58 | - | - | - |
| 2 mg RSG XR | 115 | 0.3 | 0.54 | −1.2 | −2.7, 0.4 | 0.131 | |
| 8 mg RSG XR | 112 | 0.7 | 0.57 | −0.8 | −2.4, 0.8 | 0.315 | |
| 10 mg donepezil | 49 | −0.1 | 0.79 | −1.6 | −3.5,0.3 | 0.1054 | |
| Full population | placebo | 131 | 2.0 | 0.56 | - | - | - |
| 2 mg RSG XR | 130 | 1.2 | 0.53 | −0.8 | −2.2, 0.6 | 0.272 | |
| 8 mg RSG XR | 125 | 1.2 | 0.55 | −0.8 | −2.2, 0.7 | 0.297 | |
| 10 mg donepezil | 56 | 0.6 | 0.74 | −1.3 | −3.1,0.4 | 0.1314 | |
ADAS-Cog total scores range from 0 to 70, with negative change from baseline indicating clinical improvement. LSM = Least squares mean; SE = standard error for LSM.
Model includes terms for country group, visit, APOE ε4 gene dose, treatment, baseline body mass index, baseline MMSE score, baseline MMSE score by visit, and treatment by visit
Number of subjects with an ADAS-Cog score at week 24.
Difference (active treatment minus placebo).
Unadjusted p.