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Merz memantine

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Results from two randomized, placebo-controlled European studies of memantine for treatment of mild to moderate vascular dementia presented at the Sixth International Stockholm/Springfield Symposium on Advances in Alzheimer Therapy show significant improvement in cognitive function versus placebo. One 28-week trial in 579 outpatients showed a 1.75 point mean difference in changes from baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) for memantine 10 mg twice daily compared to placebo. Investigators reported that "the largest therapeutic benefit was observed" in patients with Mini Mental-State Examination scores of less than 15. At baseline, patient MMSE scores ranged from 10 to 22. The second trial compared 10 mg twice-daily memantine to placebo over six months in 321 patients with MMSE scores of 12 to 20. Investigators reported that the ADAS-cog score improved from baseline by a mean of 0.4 in the memantine group compared to a worsening of 1.6 in the placebo group(p=0.005). A "sub-group analysis of the ADAS-cog results stratified by MMSE at baseline showed the best treatment effect for memantine in the subset of patients" with MMSE scores of less than 16. The company plans to include the studies in a European regulatory application in September. Merz and Neurobiological Technologies Inc., which is developing the agent for diabetic neuropathy, are looking for a marketing partner for regulatory development in the U.S

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