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Cognitive response to memantine in moderate to severe Alzheimer disease patients already receiving donepezil: an exploratory reanalysis.

Abstract

OBJECTIVE

To investigate the cognitive effects of the N-methyl-D-aspartate receptor antagonist, memantine, with a post-hoc exploratory reanalysis of a 24-week randomized, double-blind, placebo-controlled, parallel group clinical trial comparing memantine (20 mg per day) to placebo in patients with moderate to severe Alzheimer disease (AD) receiving treatment with the cholinesterase inhibitor, donepezil.

METHODS

The effects of memantine on individual items of the Severe Impairment Battery (SIB), subscale performance, and 3 post-hoc-derived aggregate subscales were investigated. Analyses were based on the intention-to-treat population using last observation carried forward and observed cases approaches. The SIB components were assessed at baseline, weeks 4, 8, 12, 18, and 24.

RESULTS

The mean change from baseline by visit and at study end point on the SIB showed statistically significant differences between the memantine and placebo groups at all visits beginning at week 8 (last observation carried forward and observed cases). The SIB subscale analysis showed statistically significantly greater effects of memantine than placebo on memory, language, and praxis. When the SIB domains were aggregated using a face valid approach to create 3 higher-order subscales, memantine treatment resulted in statistically significant differences on memory, language, and praxis compared with placebo.

CONCLUSIONS

These post-hoc analyses support the beneficial effects of memantine on cognition observed in a previously reported clinical trial. The results presented here suggest an effect of memantine on memory, language, and praxis in patients with moderate to severe AD and support the efficacy of memantine for the treatment of cognitive deficits in AD.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, University of Kentucky Medical Center, Sanders-Brown Center on Aging, Lexington, KY 40536, USA. fascom@email.uky.com

    , , ,

    Source

    MeSH

    Aged
    Alzheimer Disease
    Cholinesterase Inhibitors
    Cognition
    Cognition Disorders
    Donepezil
    Dopamine Agents
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Humans
    Indans
    Memantine
    Neuropsychological Tests
    Piperidines
    Placebos

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17132970

    Citation

    Schmitt, Frederick A., et al. "Cognitive Response to Memantine in Moderate to Severe Alzheimer Disease Patients Already Receiving Donepezil: an Exploratory Reanalysis." Alzheimer Disease and Associated Disorders, vol. 20, no. 4, 2006, pp. 255-62.
    Schmitt FA, van Dyck CH, Wichems CH, et al. Cognitive response to memantine in moderate to severe Alzheimer disease patients already receiving donepezil: an exploratory reanalysis. Alzheimer Dis Assoc Disord. 2006;20(4):255-62.
    Schmitt, F. A., van Dyck, C. H., Wichems, C. H., & Olin, J. T. (2006). Cognitive response to memantine in moderate to severe Alzheimer disease patients already receiving donepezil: an exploratory reanalysis. Alzheimer Disease and Associated Disorders, 20(4), pp. 255-62.
    Schmitt FA, et al. Cognitive Response to Memantine in Moderate to Severe Alzheimer Disease Patients Already Receiving Donepezil: an Exploratory Reanalysis. Alzheimer Dis Assoc Disord. 2006;20(4):255-62. PubMed PMID: 17132970.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Cognitive response to memantine in moderate to severe Alzheimer disease patients already receiving donepezil: an exploratory reanalysis. AU - Schmitt,Frederick A, AU - van Dyck,Christopher H, AU - Wichems,Christine H, AU - Olin,Jason T, AU - ,, PY - 2006/11/30/pubmed PY - 2007/2/14/medline PY - 2006/11/30/entrez SP - 255 EP - 62 JF - Alzheimer disease and associated disorders JO - Alzheimer Dis Assoc Disord VL - 20 IS - 4 N2 - OBJECTIVE: To investigate the cognitive effects of the N-methyl-D-aspartate receptor antagonist, memantine, with a post-hoc exploratory reanalysis of a 24-week randomized, double-blind, placebo-controlled, parallel group clinical trial comparing memantine (20 mg per day) to placebo in patients with moderate to severe Alzheimer disease (AD) receiving treatment with the cholinesterase inhibitor, donepezil. METHODS: The effects of memantine on individual items of the Severe Impairment Battery (SIB), subscale performance, and 3 post-hoc-derived aggregate subscales were investigated. Analyses were based on the intention-to-treat population using last observation carried forward and observed cases approaches. The SIB components were assessed at baseline, weeks 4, 8, 12, 18, and 24. RESULTS: The mean change from baseline by visit and at study end point on the SIB showed statistically significant differences between the memantine and placebo groups at all visits beginning at week 8 (last observation carried forward and observed cases). The SIB subscale analysis showed statistically significantly greater effects of memantine than placebo on memory, language, and praxis. When the SIB domains were aggregated using a face valid approach to create 3 higher-order subscales, memantine treatment resulted in statistically significant differences on memory, language, and praxis compared with placebo. CONCLUSIONS: These post-hoc analyses support the beneficial effects of memantine on cognition observed in a previously reported clinical trial. The results presented here suggest an effect of memantine on memory, language, and praxis in patients with moderate to severe AD and support the efficacy of memantine for the treatment of cognitive deficits in AD. SN - 0893-0341 UR - https://www.unboundmedicine.com/medline/citation/17132970/Cognitive_response_to_memantine_in_moderate_to_severe_Alzheimer_disease_patients_already_receiving_donepezil:_an_exploratory_reanalysis_ L2 - http://Insights.ovid.com/pubmed?pmid=17132970 DB - PRIME DP - Unbound Medicine ER -