Table 2 Efficacy analyses for the primary and secondary outcomes with the covariate model of full analysis set
From: A phase II randomized trial of sodium oligomannate in Alzheimer’s dementia
Placebo (N = 83), mean (SD) | 600 mg (N = 76), mean (SD) | 900 mg (N = 83), mean (SD) | |
|---|---|---|---|
ADAS-cog12 | |||
Baseline | 28.1 (12.0) | 26.1 (12.4) | 26.16 (12.00) |
24 Ws | 26.7 (14.5) | 24.7 (14.4) | 23.6 (13.7) |
Change | − 1.5 (7.0) | − 1.4 (6.5) | − 2.6 (5.7) |
p valuea | – | p = 0.89 | p = 0.30 |
ADCS-ADL | |||
Baseline | 50.9 (17.4) | 50.0 (17.4) | 53.7 (16.4) |
24 Ws | 49.8 (17.5) | 49.5 (18.7) | 53.2 (16.7) |
Change | − 1.1 (7.8) | − 0.5 (7.7) | − 0.5 (8.3) |
p valuea | – | 0.66 | 0.48 |
NPI | |||
Baseline | 9.9 (13.7) | 7.3 (10.9) | 7.4 (12.2) |
24 Ws | 7.8 (11.7) | 7.5 (12.2) | 6.2 (10.8) |
Change | − 2.1 (9.0) | 0.2 (7.2) | − 1.1 (11.2) |
p valuea | – | 0.17 | 0.94 |
CIBIC+ | Cases (%) | Cases (%) | Cases (%) |
Significant improvement | 3 (3.6) | 2 (2.6) | 0 (0.0) |
Moderate improvement | 6 (7.2) | 9 (11.8) | 13 (15.7) |
Slight improvement | 32 (38.6) | 18 (23.7) | 29 (34.9) |
No change | 25 (30.1) | 23 (30.3) | 35 (42.2) |
Slight deterioration | 17 (20.5) | 21 (27.6) | 4 (4.8) |
Moderate deterioration | 0 (0.0) | 3 (4.0) | 2 (2.4) |
Significant deterioration | 0 (0.0) | 0 (0.0) | 0 (0.0) |
p valueb,* | – | 0.11 | 0.01 |