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Donepezil, rivastigmine, galantamine and memantine for ...

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TABLE 16 MMSE <strong>for</strong> <strong>rivastigmine</strong><br />

BVRT<br />

The Benton Visual Retention Test (BVRT) was<br />

used as an outcome measure by Agid <strong>and</strong><br />

colleagues. 59 The low-dose (4 mg/day) group’s<br />

mean change in score was 0.3 (SD 2.6), the highdose<br />

group changed by 0.2 (SD 2.6) points on<br />

average <strong>and</strong> the placebo group’s mean change was<br />

0.2 (SD 2.7). No statistically significant differences<br />

were reported.<br />

TMT<br />

Agid <strong>and</strong> colleagues 59 reported on the Trail<br />

Making Test (TMT), which assesses speed of visual<br />

search, attention, mental flexibility <strong>and</strong> motor<br />

function. The score is the time taken to complete a<br />

test successfully. The study compared two<br />

treatment dose groups (4 <strong>and</strong> 6 mg/day) with<br />

placebo. The mean changes from baseline score<br />

were –1.6 ± 39.0, –7.3 ± 48.9 <strong>and</strong> 0.5 ± 28.7 <strong>for</strong><br />

the low-dose, high-dose <strong>and</strong> placebo groups,<br />

respectively. No statistically significant differences<br />

were observed between the two treatment groups<br />

<strong>and</strong> the placebo group.<br />

Wechsler logical memory test<br />

Forette <strong>and</strong> colleagues 60 reported on the<br />

immediate recall aspect of the Wechsler Logical<br />

Memory Test. This test is part of the Wechsler<br />

Memory Scale, which is the most frequently used<br />

clinical measure of memory in the USA. They<br />

found that participants receiving twice daily doses<br />

of <strong>rivastigmine</strong> scored better than those<br />

participants receiving treatment medication three<br />

© Queen’s Printer <strong>and</strong> Controller of HMSO 2006. All rights reserved.<br />

Health Technology Assessment 2006; Vol. 10: No. 1<br />

Agid et al., 1998 59 Mean change from baseline<br />

1. Rivastigmine 2. Rivastigmine 3. Placebo (n = 117) p-Value versus placebo<br />

4 mg/day (n = 111) 6 mg/day (n = 103)<br />

0.0 ± 3.3 0.3 ± 3.1 –0.0 ± 2.6 Not reported<br />

Corey-Bloom et al., 199857 Observed case analysis<br />

1. Rivastigmine 2. Rivastigmine 3. Placebo (n = 234) p-Value versus placebo<br />

1–4 mg/day (n = 233) 6–12 mg/day (n = 231)<br />

–0.34 0.30 –0.79 2. p < 0.05<br />

Rösler et al., 199958 Mean change from baseline (95% CI)<br />

1. Rivastigmine 2. Rivastigmine 3. Placebo (n = 239) p-Value versus placebo<br />

1–4 mg/day (n = 243 ) 6–12 mg/day (n = 243)<br />

–0.62 (–1.05 to –0.15) 0.21 (–0.24 to 0.64) –0.47 (–0.96 to –0.04) 2. p < 0.05<br />

[Commercial/academic confidential in<strong>for</strong>mation removed]<br />

[Commercial/academic confidential in<strong>for</strong>mation removed]<br />

times daily. Mean scores <strong>for</strong> these two groups<br />

were 1.8 ± 2.3 <strong>and</strong> 0.1 ± 2.3, respectively,<br />

p = 0.012.<br />

FOME<br />

Agid <strong>and</strong> colleagues 59 used the Fuld Object<br />

Memory Evaluation (FOME) as an outcome<br />

measure. They reported two aspects of the<br />

evaluation: ‘total storage’ <strong>and</strong> ‘total retrieval’. At<br />

week 13, total storage was statistically significantly<br />

better <strong>for</strong> both the high-dose group (6 mg/day)<br />

<strong>and</strong> the low-dose group (4 mg/day) than <strong>for</strong><br />

placebo (0.7 ± 6.2 <strong>and</strong> 0.4 ± 6.2 versus –0.9 ±<br />

5.5, respectively, p ≤ 0.05). For the retrieval part of<br />

the test, only the high-dose group was statistically<br />

significantly better than placebo at 13 weeks<br />

(1.1 ± 4.2 versus 0.1 ± 4.3, p ≤ 0.05).<br />

DSST<br />

Agid <strong>and</strong> colleagues 59 used the Digit Symbol<br />

Substitution Subtest (DSST) as an outcome<br />

measure. The DSST is a subset of the WAIS-R. At<br />

week 13, there was a statistically significant<br />

difference of 2.3 between the high-dose group<br />

(6 mg/day) <strong>and</strong> placebo (2.8 ± 8.1 versus 0.5 ± 6.9,<br />

p < 0.05). The difference between the low-dose<br />

group (4 mg/day) <strong>and</strong> placebo group was 1.2, but<br />

this was not statistically significant. Forette <strong>and</strong><br />

colleagues list the digit span subset of the WAIS-R<br />

as an outcome measure, but do not present results<br />

as there was no statistically significant difference<br />

found between treatment <strong>and</strong> placebo groups <strong>for</strong><br />

this test.<br />

45

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