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Table 2 Primary and secondary outcomes

From: A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

Outcome Raw score at baseline Raw score at week 36 Least square mean change at week 36 (95%CI) Estimated difference at week 36 (95% CI) p value
Placebo GV-971 Placebo GV-971 Placebo GV-971
Primary
 ADAS-Cog12* 20.83 ± 10.03 21.30 ± 10.12 20.55 ± 11.93 18.32 ± 10.71 0.26 (− 0.58, 1.10) −1.89 (− 2.78, − 1.00) − 2.15 (3.07, − 1.23) < 0.0001
Secondary
 CIBIC+** 4.0 ± 0.85 3.9 ± 0.83     0.0588
 ADCS-ADL 64.2 ± 10.1 64.0 ± 11.2 63.4 ± 11.4 63.5 ± 11.6 −1.41 (−2.18, − 0.64) −1.15 (− 1.95, − 0.35) 0.26 (−0.64, 1.16) 0.57
 NPI 5.9 ± 8.7 5.6 ± 8.0 4.8 ± 8.6 5.0 ± 7.7 −0.11 (− 0.93, 0.71) 0.01 (− 0.84, 0.87) 0.12 (− 0.84, 1.09) 0.80
  1. The plus-minus values for the scores at baseline and at 36 weeks are means (± SD). Least square means are estimated using ANCOVA, with the treatment group, education level, pooled center, and age group as fixed effects, and baseline MMSE level and baseline score as covariates. The estimated difference is the least square mean change from baseline between the two groups (GV-971 minus placebo group) at week 36. Differences may not calculate as expected because of rounding. CI denotes confidence interval
  2. *Missing data handled using control-based pattern imputation
  3. **Refer to Fig. 3. p value is obtained from a stratified Cochran-Mantel-Haenszel (CMH) test, including stratification factors of MMSE at baseline, education level, and age group