TABLE 3.
Continuous Variables Moderator Analysis: Treatment Effect at 1 SD Below Mean Value of the Moderator, Mean Value of the Moderator, and 1 SD Above the Mean Value of the Moderator Compares Mean Change in Outcome (Either ADAS-Cog or SRT Total Immediate Recall) Between Donepezil and Placebo Groups, Adjusting for Baseline Outcome Value, Age, Site, Visit Week, and Intracranial Volume for MRI Measures
| Outcome Measure | Continuous Moderator |
Treatment Effect at 1 SD Below Moderator Mean Mean (SE) |
Treatment Effect at Moderator Mean Mean (SE) |
Treatment Effect at 1 SD Above Moderator Mean Mean (SE) |
Test Statistic & p Value for Interaction |
|---|---|---|---|---|---|
| ADAS-Cog | Baseline UPSIT | 0.11 (1.53) | 1.63 (1.06) | 3.15 (1.54)b | F(1,93) = 1.85 p = 0.177 |
| HAM-D Change | 2.26 (1.45) | 1.63 (1.05) | 1.01 (1.51) | F(1,93) = 0.36 p = 0.550 | |
| Hippocampal Volume | 1.43 (1.92) | 2.11 (1.17)a | 2.80 (1.85) | F(1,80) = 0.21 p = 0.646 | |
| Entorhinal Cortex Volume | 2.33 (1.64) | 2.34 (1.22)a | 2.36 (1.71) | F(1,79) = 0.00 p = 0.990 | |
| SRT Total Immediate Recall | Baseline UPSIT | 2.95 (2.82) | 0.77 (1.99) | −1.41 (2.86) | F(1,94) = 1.15 p = 0.286 |
| HAM-D Change | −1.50 (2.74) | 0.81 (2.00) | 3.12 (2.81) | F(1,94) = 1.44 p = 0.234 | |
| Hippocampal Volume | 2.61 (3.26) | 1.98 (2.07) | 1.35 (3.36) | F(1,80) = 0.06 p = 0.807 | |
| Entorhinal Cortex Volume | 0.84 (3.08) | 1.91 (2.33) | 2.98 (3.22) | F(1,80) = 0.25 p = 0.616 |
Notes: HAM-D used is 24-item; HAM-D change: 0–16 weeks in open-label phase. ADAS-Cog used is modified 13-item. Tests for treatment effect at each moderator value are t-tests for treatment effect contrasts estimated from the corresponding mixed-effects models. Degrees of freedom for each t-test are the same as the denominator degrees of freedom for each F statistic shown in the p value for interaction column. SE: standard error.
p <0.10 for treatment effect.
p <0.05 for treatment effect.