Table 2.
End Point | Solanezumab | Placebo |
---|---|---|
Primary end point: PACC score | ||
No. of participants evaluated† | 401 | 423 |
Adjusted mean change | −1.43 | −1.13 |
Adjusted mean difference vs. placebo (95% CI)‡ | −0.30 (−0.82 to 0.22) | |
P value | 0.26 | |
CFI combined score | ||
No. of participants evaluated† | 403 | 418 |
Adjusted mean change | 2.09 | 1.51 |
Adjusted mean difference vs. placebo (95% CI)‡ | 0.58 (−0.18 to 1.34) | |
ADL partner score | ||
No. of participants evaluated† | 403 | 419 |
Adjusted mean change | −2.24 | −1.63 |
Adjusted mean difference vs. placebo (95% CI)‡ | −0.61 (−1.44 to 0.23) | |
CDR-SB score | ||
No. of participants evaluated† | 405 | 421 |
Adjusted mean change | 0.71 | 0.60 |
Adjusted mean difference vs. placebo (95% CI)‡ | 0.12 (−0.06 to 0.29) | |
Progression of the global CDR score§ | ||
No. of participants evaluated† | 406 | 424 |
Probability of progression at 240 weeks | 0.35 | 0.32 |
Results were analyzed with the use of a spline model, except for progression of the global CDR score, which was assessed in a Kaplan–Meier analysis.
Counts include all the participants who had a final visit, which was initially targeted for 240 weeks after randomization. Some participants had evaluations delayed beyond 240 weeks owing to the coronavirus disease 2019 pandemic.
95% confidence intervals were adjusted for multiple testing according to a prespecified graphical testing scheme.
Progression of the global CDR score was defined as two consecutive scores greater than zero or a final-visit score greater than zero. Global CDR scores range from 0 to 3, with 0 indicating no cognitive impairment and 3 indicating severe dementia.