Objective: Memantine, a moderate affinity, uncompetitive NMDA receptor antagonist, has been shown in several multicenter, double-blind, placebo-controlled trials to be effective and safe for use in the treatment of dementia of various stages and etiologies, including Alzheimer’s disease (AD) and vascular dementia (VaD). Memantine is approved in Europe and is under investigation in the US for the treatment of AD. There are currently no therapeutic agents indicated for VaD. This study sought to analyze the safety and tolerability of memantine in patients diagnosed with mild to moderate VaD.
Design/Methods: Data from two similarly designed double-blind, placebo-controlled trials in patients diagnosed with mild to moderate VaD (based on NINDS-AIREN criteria) were pooled. Memantine treatment began at a dose of 5 mg/day once daily, was increased by 5 mg weekly, and was maintained at the target dose of 20 mg/day (10 mg b.i.d.) for 28 weeks. Safety was assessed by monitoring adverse events (AEs), vital signs and laboratory tests. Included in these analyses and treated for a mean duration of 170 days were 442 placebo- and 460 memantine-treated patients (mean age 77 years).
Results: The percentage of patients who prematurely discontinued was similar in placebo (22%) and memantine (23%) groups. The most common reason for discontinuation was AEs (11% placebo, 13% memantine), with similar AE profiles for both groups. In both groups 74% of patients reported at least one AE. Only dizziness, constipation, and headache were reported in >5% of memantine patients at an incidence rate higher than placebo. There were no clinically important changes in vital signs or laboratory parameters from baseline to endpoint, and the percentage of patients with vital signs or laboratory parameters of potential clinical significance was small, with no noteworthy differences between memantine and placebo groups.
Conclusion: In pooled analyses, 20 mg/day memantine demonstrated a safety profile similar to that of placebo and was shown to be well tolerated and safe in the treatment of patients with vascular dementia.
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