Objective: Memantine, a moderate affinity, uncompetitive NMDA receptor antagonist, is efficacious, safe, and well tolerated in treating nursing home patients with moderate to severe dementia, including both dementia of the Alzheimer’s type (DAT) and vascular dementia (VaD)(Winblad, 1999). Here, further analyses of the DAT subpopulation were conducted.
Design/Methods: This was a 12-week randomized, double-blind, placebo-controlled study. Nursing home patients with dementia (DSM-III-R diagnostic criteria) were randomized to receive either placebo or memantine 10 mg/day, administered orally once daily. Patients were subgrouped by dementia type using the modified Hachinski Ischemia Scale into the DAT (score £4) or VaD (score >4) subpopulations. Efficacy measures included the Clinical Global Impression of Change (CGI-C)(global effects), the Behavioral Rating Scale for Geriatric Patients (BGP) care-dependency subscale (functional effects), and the BGP cognitive subscale (cognitive effects), and were analyzed using the last observation carried forward (LOCF) and observed case (OC) approaches. Safety/tolerability was assessed by monitoring adverse events, electrocardiograms, vital signs, and laboratory tests.
Results: Of 166 randomized patients, 79 were diagnosed with moderate to severe DAT (mean baseline MMSE score 6.7-6.8). Memantine-treated DAT patients showed significantly greater improvement than placebo-treated DAT patients on the CGI-C scores, BGP care-dependency subscores, and the BGP cognitive subscores (p£0.01). Significant treatment effects at Week 12 confirmed the superiority of memantine over placebo using both the LOCF and the OC approaches (p£0.01). Adverse events were similar in both groups with no clinically important changes in vital signs or laboratory parameters.
Conclusion: Memantine 10 mg/day is safe and well-tolerated, and on the basis of global, functional, and cognitive outcome measures, provides significant improvement for patients with moderate to severe dementia and more specifically for patients with DAT in a nursing home environment.
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