Table 3b.
Revised primary analysis model augmented to include an additional rate correction term as baseline-value x visit to determine whether baseline differences in severity or other characteristics account for differences seen for Comparison C at week 78 in primary and principal secondary outcomes. The baseline-value was either continuous or categorical depending on the nature of the variable
Comparison C | |||||
Baseline value used as rate correction term | 100 mg twice a day as add-on (n = 297) | Difference for 100 mg twice a day as monotherapy (n = 76) | p value | ||
ADAS-cog | ADAS-cog | Mean | 6.93 | –2.66 | 0.0058 |
95% CI | 5.85, 8.01 | –4.55, –0.77 | |||
APOE ɛ4 | Mean | 6.83 | –3.98 | 0.0002 | |
95% CI | 5.56, 8.10 | –6.08, –1.88 | |||
Vascular burden | Mean | 7.23 | –4.06 | 0.0001 | |
95% CI | 6.07, 8.39 | –6.06, –2.06 | |||
Hippocampal volume | Mean | 7.15 | –3.73 | 0.0003 | |
95% CI | 5.99, 8.31 | –5.74, –1.72 | |||
Temporo-parietal volume | Mean | 7.21 | –3.64 | 0.0002 | |
95% CI | 6.08, 8.33 | –5.59, –1.69 | |||
Temporal lobe 18F-FDG-PET SUVR | Mean | 6.95 | –2.92 | 0.0036 | |
95% CI | 5.83, 8.07 | –4.89, –0.96 | |||
ADCS-ADL | ADCS-ADL | Mean | –9.96 | 4.44 | 0.0007 |
95% CI | –11.45, –8.47 | 1.87, 7.00 | |||
APOE ɛ4 | Mean | –9.54 | 5.29 | 0.0001 | |
95% CI | –11.17, –7.90 | 2.61, 7.96 | |||
Vascular burden | Mean | –9.97 | 5.29 | 0.0001 | |
95% CI | –11.48, –8.46 | 2.72, 7.87 | |||
Hippocampal volume | Mean | –9.85 | 4.53 | 0.0006 | |
95% CI | –11.34, –8.35 | 1.95, 7.11 | |||
Temporo-parietal volume | Mean | –9.37 | 4.56 | 0.0004 | |
95% CI | –11.41, –8.45 | 2.02, 7.09 | |||
Temporal lobe 18F-FDG-PET SUVR | Mean | –9.68 | 4.19 | 0.0014 | |
95% CI | –11.16, –8.20 | 1.62, 6.77 | |||
LVV | LVV | Mean | 7.72 | –1.93 | 0.0002 |
95% CI | 7.10, 8.33 | –2.94, –0.92 | |||
APOE ɛ4 | Mean | 7.41 | –2.97 | <0.0001 | |
95% CI | 6.66, 8.16 | –4.13, –1.81 | |||
Vascular burden | Mean | 7.74 | –3.21 | <0.0001 | |
95% CI | 7.03, 8.46 | –4.35, –2.07 | |||
Hippocampal volume | Mean | 7.69 | –2.94 | <0.0001 | |
95% CI | 6.98, 8.40 | –4.09, –1.79 | |||
Temporo-parietal volume | Mean | 7.71 | –3.05 | <0.0001 | |
95% CI | 7.00, 8.42 | –4.19, –1.91 | |||
Temporal lobe 18F-FDG-PET SUVR | Mean | 7.53 | –2.25 | 0.0001 | |
95% CI | 6.86, 8.21 | –3.36, –1.14 |