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

Table 2 Primary and secondary outcomes

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
Outcome	Placebo	GV-971	Placebo	GV-971	Placebo	GV-971	Estimated difference at week 36 (95% CI)	p value
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

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
*Missing data handled using control-based pattern imputation
**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

ISSN: 1758-9193