Memantine in severe dementia: results of the 9M-best study (benefit and efficacy in severly demented patients during treatment with memantine)
✍ Scribed by B. Winblad; N. Poritis
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 175 KB
- Volume
- 14
- Category
- Article
- ISSN
- 0885-6230
No coin nor oath required. For personal study only.
✦ Synopsis
Objectives:
To assess clinical efficacy and safety of memantine--an uncompetitive n-methyl-d-aspartate (nmda) antagonist--in moderately severe to severe primary dementia.
Materials and methods:
Dementia was defined by dsm-iii-r criteria and severity was assessed by the global deterioration scale (stages 5-7) and the mini-mental state examination (< 10 points). primary endpoints were the clinical global impression of change (cgi-c) rated by the physician, and the behavioural rating scale for geriatric patients (bgp), subscore 'care dependence', rated by the nursing staff. secondary endpoints included the modified d-scale (arnold/ferm).
Results:
The itt sample comprised 166 patients and 151 patients were treated per protocol. at 12-week itt endpoint analysis, 82 received memantine 10 mg per day, 84 placebo. dementia was in 49% of the alzheimer type and in 51% of the vascular type (ct, hachinski score). a positive response in the cgi-c was seen in 73% versus 45% in favour of memantine (stratified wilcoxon p < 0.001), independent of the etiology of dementia. the results in the bgp subscore 'care dependence' were 3.1 points improvement under memantine and 1.1 points under placebo (p = 0.016). a coincident response of the two independent target variables was observed in 61.3% (memantine) versus 31.6% (placebo). secondary endpoint analysis of the d-scale assessing basic adl functions support the primary results. regarding the safety profile, no significant differences between treatment groups were observed.
Conclusions:
The results of this trial support the hypothesis that memantine treatment leads to functional improvement and reduces care dependence in severely demented patients.