Assessment of treatment effect of donepezil and vitamin E compared with placebo
| ADCS-MCI (12 months) | Eisai-AD-302 (6 months) | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Donepezil | Vitamin E | Placebo | Donepezil | Donepezil | ||
| Endpoint | Statistics | (208) | 10 mg (182) | (208) | (71) | 5 mg (74) | 10 mg (56) |
| ADCOMS | LSMean (SE) | 0.061 (0.0080) | 0.034 (0.0085) | 0.060 (0.0080) | 0.053 (0.014) | −0.005 (0.014) | −0.033 (0.016) |
| Difference (SE) | 0.027 (0.0117) | 0.002 (0.0113) | 0.057 (0.020) | 0.085 (0.022) | |||
| 95% CI | 0.005 to 0.050 | −0.021 to 0.024 | 0.018 to 0.096 | 0.043 to 0.128 | |||
| p Value | 0.019 | 0.885 | 0.0041 | <0.0001 | |||
| ADAS-cog | LSMean (SE) | 0.79 (0.309) | 0.08 (0.328) | 0.93 (0.311) | 1.6 (0.552) | –0.67 (0.535) | −1.23 (0.627) |
| Difference (SE) | 0.71 (0.451) | −0.14 (0.439) | 2.27 (0.769) | 2.83 (0.835) | |||
| 95% CI | −0.18 to 1.59 | −1.00 to 0.72 | 0.76 to 3.78 | 1.19 to 4.47 | |||
| p Value | 0.116 | 0.755 | 0.0033 | 0.0008 | |||
| MMSE | LSMean (SE) | −0.71 (0.152) | −0.20 (0.163) | −0.60 (0.154) | −0.75 (0.313) | 0.83 (0.301) | 0.49 (0.358) |
| Difference (SE) | −0.51 (0.223) | −0.12 (0.217) | −1.58 (0.434) | −1.24 (0.476) | |||
| 95% CI | −0.94 to −0.07 | −0.54 to 0.31 | −2.43 to −0.72 | −2.17 to −0.30 | |||
| p Value | 0.024 | 0.594 | 0.0003 | 0.0095 | |||
| CDR-SB | LSMean (SE) | 0.38 (0.068) | 0.22 (0.073) | 0.46 (0.068) | 0.24 (0.117) | −0.10 (0.113) | –0.19 (0.134) |
| Difference (SE) | 0.16 (0.099) | −0.08 (0.096) | 0.33 (0.163) | 0.43 (0.178) | |||
| 95% CI | −0.03 to 0.36 | −0.27 to 0.11 | 0.01 to 0.65 | 0.08 to 0.78 | |||
| p Value | 0.107 | 0.419 | 0.0414 | 0.0173 | |||
AD, Alzheimer's dementia; ADAS-cog, Alzheimer's Disease Assessment Scale–cognitive subscale; ADCOMS, Alzheimer's Disease clinical COMposite Score; CDR-SB, Clinical Dementia Rating, sum of boxes; LSMean, least squares means; aMCI, amnestic mild cognitive impairment; MMSE, Mini-Mental State Exam; SE, Standard Error.