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翻译样稿北京华译网翻译公司翻译样稿北京华译网翻译公司翻译样稿北京华译网翻译公司的长期扩展研究等为期周的双盲研究结束后名完成试验者美金刚组或者安慰剂组被再次滴定并继续周开放的美金刚研究每天患者在最初的周治疗期保持盲态在双盲期美金刚组患者的恶化速度明显慢于安慰剂组在长期有效性分析中有效性评价方法评价了患者周期间的恶化程度评价指标涉及整翻译样稿北京华译网翻译公司翻译样稿北京华译网翻译公司体状况功能及认知能力结果在扩展期前面服用安慰剂的患者改为服用美金刚后患者的恶化程度明显减慢在整体状况功能及认知能力三
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Long-term extension of MRZ-9605 (Reisberg et al, 2006)58
Following on from the 28-week, double-blind phase of study MRZ-9605, 175
‘completers’ (memantine or placebo) were re-titrated and continued on
open-label memantine (20 mg/day) for a further 24 weeks. Patients remained
blinded to their initial 28-week treatment.
In the double-blind phase, patients who took memantine declined at a
significantly slower rate than those who took placebo.10 In the long-term
analysis, efficacy measures assessed the rate of decline in patients over the whole
52-week period, in the domains of global status, function and cognition.
Results
• The rate of decline in patients in the former placebo group slowed
significantly upon their switch to memantine in the extension phase – the change
in rate of decline was statistically significant in all three domains (Figure 6.18).
• The rate of decline in patients who received memantine in both phases of the
study varied across efficacy measures. Comparing outcome in the open-label
phase with the double-blind phase, the rate of global decline decreased
significantly (p0.001, OC analysis), the rate of cognitive decline remained
unchanged, and the rate of functional decline increased (Figure 6.19).
Long-term extension of Lu-99679 (Bakchine et al, 2007)59
The 148-week extension of study Lu-99679 assessed the decline/rate of disease
progression of patients treated with memantine compared to untreated patients,
and TEAEs between groups.
Completers of the 24-week, randomised, double-blind, placebo-controlled,
6-month
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