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| |  Memantine Benefits Functional Communication in Patients With Moderate Alzheimer’s Disease: Presented at ECNP By Jenny Powers ISTANBUL, Turkey -- September 18, 2009 -- Memantine treatment may benefit both patients and caregivers by improving language and conversation abilities in patients with Alzheimer’s disease (AD), according to researchers here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress. Judith Saxton, PhD, Department of Neurology, Alzheimer’s Disease Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, reported the results of a study that examined the effect of memantine on communication ability in patients with AD on September 13. This international, double-blind study used novel measures of functional communication to evaluate the effects of memantine in patients with moderate AD. Native English-speaking outpatients with AD (Mini-Mental State Exam range 10-19) were randomised to receive memantine 20 mg/day or placebo for 12 weeks. The double-blind phase followed <=2 weeks of single-blind treatment with only placebo. Patients could continue to use a cholinesterase inhibitor if they were on a stable dosage before the trial, but they were required to maintain the same therapy throughout the study. The study’s primary outcome was the least squares (LS) score change on the Functional Linguistic Communication Inventory (FLCI), which directly measures a patient’s ability to communicate. The secondary endpoint was the LS score change on the combined Social Communication and Communication of Basic Needs subscales of the American Speech-Language-Hearing Association Functional Assessment Communication Skills for Adults (ASHA FACS). A 2-way analysis of covariance model (with treatment group and study centre as factors and baseline score as covariate) was used to analyse the intent-to-treat population and the last observation carried forward (LOCF). Observed cases and the mixed-effects model with repeated measures (MMRM; FLCI only) were used for further analyses. Safety and tolerability assessments were based on treatment-emergent adverse events. Compared with patients on placebo (n = 124), researchers found a statistically significant mean (+- standard error) LS improvement (LOCF) on the FLCI in patients treated with memantine (n = 133) at weeks 4 (P = .028) and 8 (P = .015) that was not seen at week 12 (placebo, -0.6 +- 0.6; memantine, 0.7 +- 0.6; P = .070). The observed-cases analysis results were similar between groups; and, according to MMRM analysis (week 4, P = .058; week 8, P = .022; week 12, P = .097), memantine had a statistically significant effect across the trial (P = .021). By LOCF analysis, memantine showed a statistically significant improvement over placebo in LS mean (ASHA FACS) at 8 (P = .008) and 12 (placebo, -5.3 +- 2.1 vs memantine, 0.5 +- 2.0; P = .022) weeks. The results were similar for OC analysis. The only side effects reported (0.2% of memantine patients) were dizziness and restlessness. No adverse events occurred. Funding for this study was provided by Forest Laboratories Inc. [Presentation title: Effects of Memantine on Functional Communication in Moderate Alzheimer’s Disease: Results of a 12-Week Placebo-Controlled Trial. Abstract P.5.a.008]
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