Table 2.
Changes in cognitive and neuropsychiatric scores, health-related quality of life, and frontal lobe volume between baseline and 24 months
|
Combined |
Placebo |
Simvastatin |
Treatment effect (95% CI) | p value | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Change (95% CI) | p value | N | Change (95% CI) | N | Change (95% CI) | ||||
| Cognitive scores | ||||||||||
| Wechsler Abbreviated Scale of Intelligence* | ||||||||||
| Overall IQ | 135 | −0·2 (−1·4 to 0·9) | 0·67 | 68 | −0·3 (−1·9 to 1·3) | 67 | −0·2 (−1·7 to 1·3) | 0·1 (−2·0 to 2·2) | 0·92 | |
| Verbal IQ | 136 | −1·4 (−2·8 to 0·0) | 0·058 | 68 | −1·2 (−3·2 to 0·7) | 68 | −1·5 (−3·4 to 0·3) | −0·3 (−2·8 to 2·2) | 0·82 | |
| Performance IQ | 135 | 0·8 (−0·2 to 1·8) | 0·13 | 68 | 0·3 (−1·1 to 1·8) | 67 | 1·2 (−0·1 to 2·6) | 0·9 (−1·0 to 2·9) | 0·35 | |
| Vocabulary | 137 | −1·2 (−3·0 to 0·5) | 0·17 | 68 | −1·3 (−3·7 to 1·1) | 69 | −1·1 (−3·4 to 1·2) | 0·2 (−2·9 to 3·3) | 0·90 | |
| Similarities | 136 | −0·8 (−2·3 to 0·7) | 0·30 | 67 | −0·6 (−2·7 to 1·5) | 69 | −1·0 (−2·9 to 1·0) | −0·3 (−3·1 to 2·4) | 0·80 | |
| Block design | 136 | 0·6 (−0·5 to 1·7) | 0·29 | 68 | −0·4 (−2·0 to 1·2) | 68 | 1·6 (0·1 to 3·2) | 2·1 (−0·1 to 4·3) | 0·064 | |
| Matrix reasoning | 136 | 0·9 (−0·8 to 2·6) | 0·30 | 68 | 1·4 (−1·0 to 3·8) | 68 | 0·4 (−1·9 to 2·7) | −1·0 (−4·2 to 2·2) | 0·55 | |
| Graded Naming Test* | 135 | −0·5 (−1·7 to 0·7) | 0·44 | 68 | −0·3 (−2·0 to 1·4) | 67 | −0·7 (−2·3 to 0·9) | −0·4 (−2·7 to 1·9) | 0·75 | |
| Birt Memory and Information Processing Battery* | ||||||||||
| Story: immediate recall | 136 | −2·5 (−4·5 to −0·4) | 0·018 | 68 | −3·0 (−6·0 to −0·1) | 68 | −2·0 (−4·7 to 0·8) | 1·1 (−2·9 to 5·0) | 0·60 | |
| Story: delayed recall | 136 | −5·7 (−7·8 to −3·6) | <0·0001 | 68 | −6·5 (−9·5 to −3·4) | 68 | −5·0 (−7·8 to −2·1) | 1·5 (−2·6 to 5·7) | 0·47 | |
| Figure copying: immediate recall | 135 | −1·8 (−4·1 to 0·5) | 0·12 | 68 | −1·4 (−4·8 to 1·9) | 67 | −2·2 (−5·3 to 0·8) | −0·8 (−5·2 to 3·6) | 0·72 | |
| Figure copying: delayed recall | 135 | −6·8 (−8·7 to −4·8) | <0·0001 | 68 | −7·0 (−9·9 to −4·2) | 67 | −6·5 (−9·1 to −3·9) | 0·5 (−3·4 to 4·4) | 0·79 | |
| VOSP cube analysis† | 137 | 0·0 (−0·3 to 0·3) | .. | 69 | 0·0 (−0·4 to 0·3) | 68 | 0·0 (−0·4 to 0·4) | 0·0 (−0·5 to 0·5) | .. | |
| Frontal Assessment Battery† | 138 | −0·3 (−0·9 to 0·3) | .. | 69 | −0·9 (−1·9 to −0·1) | 69 | 0·3 (−0·4 to 0·9) | 1·2 (0·2 to 2·3) | .. | |
| Paced Auditory Serial Addition Test | 140 | 2·0 (−0·2 to 4·2) | 0·074 | 70 | 0·0 (−3·1 to 3·2) | 70 | 3·9 (1·0 to 6·8) | 3·9 (−0·3 to 8·1) | 0·070 | |
| Neuropsychiatric measures | ||||||||||
| Hamilton Depression Rating Scale | 138 | 2·8 (1·5 to 4·0) | <0·0001 | 69 | 3·3 (1·6 to 5·0) | 69 | 2·3 (0·7 to 3·8) | −1·0 (−3·2 to 1·2) | 0·37 | |
| NPIQ severity† | 127 | 0·5 (−0·7 to 1·7) | .. | 64 | 0·7 (−0·7 to 2·6) | 63 | 0·2 (−1·4 to 1·6) | −0·6 (−2·7 to 1·6) | .. | |
| NPIQ distress† | 127 | 1·0 (−0·4 to 2·5) | .. | 64 | 1·6 (−0·5 to 3·9) | 63 | 0·3 (−1·3 to 1·9) | −1·3 (−3·9 to 1·1) | .. | |
| Health-related quality of life* | ||||||||||
| Mental component score | 136 | −0·8 (−3·0 to 1·4) | 0·48 | 67 | −0·7 (−3·8 to 2·3) | 69 | −0·8 (−3·7 to 2·0) | −0·1 (−4·0 to 3·8) | 0·96 | |
| Physical component score | 136 | −0·6 (−1·9 to 0·7) | 0·36 | 67 | −1·9 (−3·6 to −0·1) | 69 | 0·7 (−1·0 to 2·3) | 2·5 (0·3 to 4·8) | 0·028 | |
| Physical functioning† | 138 | −2·5 (−3·8 to −1·4) | .. | 68 | −2·3 (−4·0 to −0·7) | 70 | −2·8 (−4·4 to −1·4) | −0·5 (−2·8 to 1·5) | .. | |
| Role limitations–physical† | 137 | 0·8 (−1·2 to 2·7) | .. | 68 | −0·5 (−2·9 to 1·9) | 69 | 2·1 (−0·6 to 4·8) | 2·6 (−0·7 to 6·0) | .. | |
| Bodily pain | 139 | −1·0 (−2·6 to 0·7) | 0·24 | 69 | −1·7 (−4·0 to 0·7) | 70 | −0·3 (−2·5 to 1·9) | 1·4 (−1·7 to 4·4) | 0·39 | |
| General health | 139 | −0·1 (−1·6 to 1·4) | 0·89 | 69 | 0·1 (−2·1 to 2·3) | 70 | −0·3 (−2·3 to 1·7) | −0·4 (−3·3 to 2·4) | 0·77 | |
| Vitality | 137 | 0·2 (−1·4 to 1·8) | 0·82 | 68 | 0·3 (−1·9 to 2·6) | 69 | 0·0 (−2·1 to 2·2) | −0·3 (−3·2 to 2·7) | 0·85 | |
| Social functioning | 139 | −1·9 (−4·2 to 0·5) | 0·12 | 69 | −0·8 (−4·0 to 2·4) | 70 | −2·9 (−5·9 to 0·1) | −2·1 (−6·2 to 2·0) | 0·31 | |
| Role limitations–emotional† | 139 | −1·4 (−4·1 to 1·3) | .. | 69 | −2·3 (−6·0 to 1·3) | 70 | −0·5 (−4·2 to 2·9) | 1·8 (−2·9 to 6·3) | .. | |
| Mental health | 138 | −1·3 (−3·2 to 0·6) | 0·19 | 68 | −0·5 (−3·1 to 2·1) | 70 | −2·0 (−4·5 to 0·4) | −1·5 (−4·9 to 1·9) | 0·38 | |
| MRI | ||||||||||
| Frontal lobe atrophy (mL/year)‡ | 140 | −1·0 (−1·3 to −0·6) | <0·0001 | 70 | −1·0 (−1·5 to −0·4) | 70 | −0·9 (−1·4 to −0·4) | 0·0 (−0·7 to 0·7) | 0·97 | |
Imaging was done between baseline and 25 months. IQ=intelligence quotient. VOSP=Visual Object and Space Perception. NPIQ=Neuropsychiatric Inventory Questionnaire.
*
T score.
†
As a result of bootstrapping, p values cannot be provided; however, significance (p<0·05) can be inferred by the 95% CI not crossing zero.
‡
Post-hoc analysis.