Table 2.
Treatment Assignment | |||||
---|---|---|---|---|---|
Cognitive Test | Folic acid / B6 / B12 | Placebo | |||
Cognitive Assessment | No. of subjects | Mean (SE) * | No. of subjects | Mean (SE) * | Mean difference [B vitamin Group - Placebo Group] (95% CI) † |
PRIMARY ENDPOINT: Global score ‡ | |||||
1 | 1002 | 0.00 (0.02) | 1007 | −0.01 (0.02) | 0.01 (−0.05, 0.07) |
2 | 911 | 0.06 (0.03) | 923 | 0.01 (0.02) | 0.05 (−0.01, 0.12) |
3 | 850 | −0.04 (0.03) | 845 | −0.07 (0.03) | 0.02 (−0.06, 0.10) |
4 | 521 | −0.02 (0.03) | 532 | −0.07 (0.03) | 0.05 (−0.04,0.14) |
KEY SECONDARY ENDPOINT: Verbal memory score ‡ | |||||
1 | 1002 | 0.00 (0.02) | 1007 | 0.00 (0.02) | 0.01 (−0.06, 0.07) |
2 | 911 | 0.07 (0.03) | 923 | 0.01 (0.03) | 0.06 (−0.02, 0.13) |
3 | 850 | 0.03 (0.03) | 845 | 0.03 (0.03) | 0.00 (−0.07, 0.08) |
4 | 521 | 0.03 (0.03) | 532 | −0.04 (0.03) | 0.06 (−0.03, 0.16) |
TICS score ‡ | |||||
1 | 1002 | 34.35 (0.10) | 1007 | 34.38 (0.10) | −0.04 (−0.31, 0.24) |
2 | 911 | 34.39 (0.11) | 923 | 34.30 (0.10) | 0.09 (−0.21, 0.39) |
3 | 850 | 34.05 (0.11) | 845 | 33.94 (0.13) | 0.12 (−0.22, 0.45) |
4 | 521 | 33.94 (0.13) | 532 | 33.64 (0.15) | 0.30 (−0.09, 0.69) |
Category fluency score | |||||
1 | 1000 | 16.65 (0.16) | 1007 | 16.32 (0.15) | 0.34 (−0.09, 0.76) |
2 | 909 | 16.82 (0.17) | 921 | 16.49 (0.16) | 0.33 (−0.12, 0.79) |
3 | 846 | 15.65 (0.17) | 840 | 15.33 (0.18) | 0.32 (−0.16, 0.80) |
4 | 519 | 16.46 (0.20) | 530 | 16.57 (0.19) | −0.11 (−0.65,0.43) |
Least squares means and standard errors
From longitudinal linear models of least square means of cognitive performance at each assessment
TICS = Telephone Interview of Cognitive Status;
Verbal score is a composite score of the z-scores of the immediate and delayed recalls of both the TICS 10-word and the East Boston Memory Test;
Global score is a composite score of the z-scores of TICS, immediate and delayed recalls of the East Boston Memory Test, category fluency, delayed recall of the TICS 10-word list