Skip to main content
. Author manuscript; available in PMC: 2024 Mar 21.
Published in final edited form as: N Engl J Med. 2023 Jul 17;389(12):1096–1107. doi: 10.1056/NEJMoa2305032

Table 2.

Primary and Secondary End Points (Modified Intention-to-Treat Population).*

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.