Table 2.
Scores on Primary and Secondary Outcome Measures at Baseline and 12 Weeks
| Mean (SD) | β (95% Confidence Interval) | |||
|---|---|---|---|---|
| Baselinea | 12 Weeksb | Univariate Differenceb,c | Multivariate Differenceb,d | |
| Primary Outcome Measures | ||||
| Rey CFT (delayed recall) | ||||
| Placebo | −1.6 (0.7) | −1.5 (1.0) | ]0.07 (−0.37 to 0.51) | 0.10 (−0.36 to 0.56) |
| Simvastatin | −1.7 (0.8) | −1.4 (0.8) | ||
| Cancellation test (speed)e | ||||
| Placebo | −0.8 (1.6) | 0.4 (1.1) | ]−0.27 (−0.74 to 0.20) | −0.19 (−0.67 to 0.29) |
| Simvastatin | −1.2 (1.8) | −0.1 (1.4) | ||
| Prism adaptation, No. (%)f | ||||
| Placebo | 12 (44) | 10 (37) | ]1.57 (0.48 to 5.13)g | 2.01 (0.55 to 7.37)g |
| Simvastatin | 11 (50) | 12 (48) | ||
| Mean ADC value, × 10−3 mm2/sh | ||||
| Placebo | 8.03 (0.52) | 7.97 (0.50) | ]0.01 (−0.12 to 0.14) | 0.06 (−0.07 to 0.20) |
| Simvastatin | 8.02 (0.44) | 7.91 (0.46) | ||
| Secondary Outcome Measures | ||||
| Cancellation test (standard deviation) (raw score)i | ||||
| Placebo | −2.7 (1.2) | −1.9 (0.9) | ]−0.12 (−0.65 to 0.41) | −0.26 (−0.80 to 0.28) |
| Simvastatin | −2.8 (1.7) | −2.0 (1.5) | ||
| Stroop (speed)j | ||||
| Placebo | −0.2 (1.8) | 0.2 (1.5) | ]0.34 (−0.36 to 1.04) | 0.48 (−0.23 to 1.18) |
| Simvastatin | −0.5 (2.1) | 0.3 (1.9) | ||
| Block design | ||||
| Placebo | −1.1 (0.8) | −1.0 (1.0) | ]0.15 (−0.18 to 0.47) | 0.10 (−0.24 to 0.44) |
| Simvastatin | −0.8 (0.9) | −0.5 (1.0) | ||
| Object assembly | ||||
| Placebo | −1.1 (1.1) | −0.9 (1.3) | ]0.50 (0.05 to 0.95)k | 0.54 (0.08 to 1.01)l |
| Simvastatin | −0.8 (1.1) | −0.1 (1.0) | ||
| Rey CFT (copy) | ||||
| Placebo | −1.2 (1.2) | −0.7 (1.1) | ]−0.26 (−0.71 to 0.19) | −0.12 (−0.58 to 0.34) |
| Simvastatin | −1.4 (1.3) | −1.0 (1.2) | ||
| Beery VMI | ||||
| Placebo | −1.2 (0.9) | −1.1 (0.9) | ]−0.01 (−0.27 to 0.26) | −0.02 (−0.30 to 0.26) |
| Simvastatin | −1.2 (0.7) | −1.1 (0.7) | ||
| Judgment of line orientation test | ||||
| Placebo | −1.6 (1.4) | −1.1 (1.6) | ]−0.12 (−0.62 to 0.38) | −0.06 (−0.58 to 0.46) |
| Simvastatin | −1.1 (1.4) | −0.8 (1.6) | ||
Abbreviations: ADC, apparent diffusion coefficient; Beery VMI, Beery developmental test of visual-motor integration; CFT, complex figure test; NF1, neurofibromatosis type 1.
N = 62 (31 placebo, 31 simvastatin) unless otherwise indicated. Values indicate mean (SD) z score unless otherwise indicated in which negative values indicate performance below the normative mean and positive values performance above the normative mean.
n = 61 (31 placebo, 30 simvastatin) unless otherwise indicated; 1 loss to follow-up in the simvastatin group before final assessment. Values indicate mean (SD) z score unless otherwise indicated in which negative values indicate performance below the normative mean and positive values performance above the normative mean.
Values (regression coefficients and 95% confidence interval) indicate between-group differences in scores after 12 weeks, adjusted for baseline scores, obtained from univariate regression analysis.
Values (regression coefficients and 95% confidence interval) indicate between-group differences in scores after 12 weeks, adjusted for baseline scores, age, and sex, obtained from multivariate regression analysis.
Baseline and 12 weeks: n = 29 in the placebo group; only administered if children possessed sufficient rote memory to count groups of up to 5 dots.
Baseline: n = 49 (27 placebo, 22 simvastatin); 7 left-handed children excluded, 6 children excluded due to technical problems, including not understanding or adhering to task instructions (n = 4). 12 Weeks: n = 52 (27 placebo, 25 simvastatin); 6 left-handed children excluded, 3 children excluded due to technical problems including not understanding/adhering to task instructions (n = 2).
Odds ratio with 95% confidence interval. n = 46 (26 placebo, 20 simvastatin), 6 left-handed children excluded, 9 children excluded because of technical problems, including not adhering to task instructions (n = 6).
Baseline: n = 50 (25 placebo, 25 simvastatin); 2 missing due to artifacts, 10 were not scanned due to limited magnetic resonance imaging capacity (random). 12 Weeks: n = 46 (23 placebo, 23 simvastatin); 5 missing due to artifacts, 10 were not scanned due to limited magnetic resonance imaging capacity (random). A decrease in ADC values indicates lower signal intensity.
Baseline and 12 weeks: n = 29 in the placebo group; only administered if children possessed sufficient rote memory to count groups of up to 5 dots. Larger negative values indicate larger attention fluctuations.
Baseline: n = 59 (29 placebo, 30 simvastatin); 12 weeks: n = 58 (29 placebo, 29 simvastatin). Only administered if children could read the names of colors.
P = .03.
P = .02.