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Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial.

Abstract

OBJECTIVE

The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD).

METHOD

This was a randomized, double-blind, placebo-controlled clinical trial conducted at 42 U.S. sites. Participants were 403 outpatients with mild to moderate AD and Mini-Mental State Examination scores of 10-22 randomized to memantine (20 mg/day; N=201) or placebo (N=202) for 24 weeks. Primary outcomes were change from baseline at 24 weeks on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), a measure of cognition, and on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), a global measure. Secondary outcomes included change on the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL(23)), measures of behavior and function, respectively.

RESULTS

Most (82.4%) participants completed the trial. Memantine resulted in significantly better outcomes than placebo on measures of cognition, global status, and behavior when based on the protocol-specified primary last observation carried forward imputation as well as a mixed-models repeated-measures approach applied to the continuous outcomes. Treatment discontinuations because of adverse events for memantine versus placebo were 19 (9.5%) and 10 (5.0%), respectively.

CONCLUSIONS

These results support the safety and efficacy of memantine for the treatment of mild to moderate AD.

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  • Authors+Show Affiliations

    ,

    Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine and Veterans Affairs Northwest Network Mental Illness Research, Education, and Clinical Center, Seattle, WA 98108, USA. peskind@u.washington.edu

    , , , , ,

    Source

    MeSH

    Aged
    Alzheimer Disease
    Cognition
    Double-Blind Method
    Drug-Related Side Effects and Adverse Reactions
    Excitatory Amino Acid Antagonists
    Female
    Humans
    Male
    Memantine
    Neuropsychological Tests

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16861375

    Citation

    Peskind, Elaine R., et al. "Memantine Treatment in Mild to Moderate Alzheimer Disease: a 24-week Randomized, Controlled Trial." The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, vol. 14, no. 8, 2006, pp. 704-15.
    Peskind ER, Potkin SG, Pomara N, et al. Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. Am J Geriatr Psychiatry. 2006;14(8):704-15.
    Peskind, E. R., Potkin, S. G., Pomara, N., Ott, B. R., Graham, S. M., Olin, J. T., & McDonald, S. (2006). Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, 14(8), pp. 704-15.
    Peskind ER, et al. Memantine Treatment in Mild to Moderate Alzheimer Disease: a 24-week Randomized, Controlled Trial. Am J Geriatr Psychiatry. 2006;14(8):704-15. PubMed PMID: 16861375.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. AU - Peskind,Elaine R, AU - Potkin,Steven G, AU - Pomara,Nunzio, AU - Ott,Brian R, AU - Graham,Stephen M, AU - Olin,Jason T, AU - McDonald,Scott, PY - 2006/7/25/pubmed PY - 2006/10/14/medline PY - 2006/7/25/entrez SP - 704 EP - 15 JF - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JO - Am J Geriatr Psychiatry VL - 14 IS - 8 N2 - OBJECTIVE: The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD). METHOD: This was a randomized, double-blind, placebo-controlled clinical trial conducted at 42 U.S. sites. Participants were 403 outpatients with mild to moderate AD and Mini-Mental State Examination scores of 10-22 randomized to memantine (20 mg/day; N=201) or placebo (N=202) for 24 weeks. Primary outcomes were change from baseline at 24 weeks on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), a measure of cognition, and on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), a global measure. Secondary outcomes included change on the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL(23)), measures of behavior and function, respectively. RESULTS: Most (82.4%) participants completed the trial. Memantine resulted in significantly better outcomes than placebo on measures of cognition, global status, and behavior when based on the protocol-specified primary last observation carried forward imputation as well as a mixed-models repeated-measures approach applied to the continuous outcomes. Treatment discontinuations because of adverse events for memantine versus placebo were 19 (9.5%) and 10 (5.0%), respectively. CONCLUSIONS: These results support the safety and efficacy of memantine for the treatment of mild to moderate AD. SN - 1064-7481 UR - https://www.unboundmedicine.com/medline/citation/16861375/Memantine_treatment_in_mild_to_moderate_Alzheimer_disease:_a_24_week_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1064-7481(12)60572-7 DB - PRIME DP - Unbound Medicine ER -