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A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil.

Abstract

OBJECTIVE

The objective of this study was to examine the clinical utility of memantine for moderate-to-severe Alzheimer disease (AD) using responder analyses.

METHOD

Data from a previously published 24-week, randomized, double-blind, placebo-controlled trial of 10 mg memantine twice a day in patients with moderate-to-severe AD (N = 404) on stable donepezil therapy were evaluated using three sets of responder criteria. Response rates were calculated and analyzed for the intention-to-treat population using a generalized estimating equations model. The following outcomes were examined separately and in combination: the Alzheimer's Disease Cooperative Study-Activities of Daily Living 19-Item Inventory (ADCS-ADL19), Severe Impairment Battery (SIB), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), and Neuropsychiatric Inventory (NPI).

RESULTS

When treatment response required cognitive improvement relative to baseline, memantine yielded higher response rates than placebo. When treatment response was defined as stabilization of individual outcomes, memantine resulted in significantly higher response rates than placebo for all outcomes, with number needed to treat (NNT) ranging from 8-10. More conservative definitions of response that required simultaneous stabilization on multiple outcome measures again favored memantine treatment for six of 10 combinatorial definitions.

CONCLUSIONS

These responder analyses may assist clinicians in evaluating the impact of memantine in a relevant clinical scenario, i.e., in patients with AD previously stabilized on a cholinesterase inhibitor. The current results indicate that in this setting, memantine produces both improvement and stabilization of symptoms, across multiple outcomes, and thus provides a clinically important treatment benefit for patients with moderate-to-severe AD.

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  • Authors+Show Affiliations

    ,

    Department of Psychiatry, Yale University, New Haven, Connecticut 06510, USA. christopher.vandyck@yale.edu

    , ,

    Source

    MeSH

    Activities of Daily Living
    Aged
    Alzheimer Disease
    Cholinesterase Inhibitors
    Donepezil
    Dopamine Agents
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Geriatric Assessment
    Humans
    Indans
    Male
    Memantine
    Neuropsychological Tests
    Piperidines
    Severity of Illness Index
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16670247

    Citation

    van Dyck, Christopher H., et al. "A Responder Analysis of Memantine Treatment in Patients With Alzheimer Disease Maintained On Donepezil." The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, vol. 14, no. 5, 2006, pp. 428-37.
    van Dyck CH, Schmitt FA, Olin JT, et al. A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil. Am J Geriatr Psychiatry. 2006;14(5):428-37.
    van Dyck, C. H., Schmitt, F. A., & Olin, J. T. (2006). A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil. The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, 14(5), pp. 428-37.
    van Dyck CH, et al. A Responder Analysis of Memantine Treatment in Patients With Alzheimer Disease Maintained On Donepezil. Am J Geriatr Psychiatry. 2006;14(5):428-37. PubMed PMID: 16670247.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil. AU - van Dyck,Christopher H, AU - Schmitt,Frederick A, AU - Olin,Jason T, AU - ,, PY - 2006/5/4/pubmed PY - 2006/8/10/medline PY - 2006/5/4/entrez SP - 428 EP - 37 JF - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JO - Am J Geriatr Psychiatry VL - 14 IS - 5 N2 - OBJECTIVE: The objective of this study was to examine the clinical utility of memantine for moderate-to-severe Alzheimer disease (AD) using responder analyses. METHOD: Data from a previously published 24-week, randomized, double-blind, placebo-controlled trial of 10 mg memantine twice a day in patients with moderate-to-severe AD (N = 404) on stable donepezil therapy were evaluated using three sets of responder criteria. Response rates were calculated and analyzed for the intention-to-treat population using a generalized estimating equations model. The following outcomes were examined separately and in combination: the Alzheimer's Disease Cooperative Study-Activities of Daily Living 19-Item Inventory (ADCS-ADL19), Severe Impairment Battery (SIB), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), and Neuropsychiatric Inventory (NPI). RESULTS: When treatment response required cognitive improvement relative to baseline, memantine yielded higher response rates than placebo. When treatment response was defined as stabilization of individual outcomes, memantine resulted in significantly higher response rates than placebo for all outcomes, with number needed to treat (NNT) ranging from 8-10. More conservative definitions of response that required simultaneous stabilization on multiple outcome measures again favored memantine treatment for six of 10 combinatorial definitions. CONCLUSIONS: These responder analyses may assist clinicians in evaluating the impact of memantine in a relevant clinical scenario, i.e., in patients with AD previously stabilized on a cholinesterase inhibitor. The current results indicate that in this setting, memantine produces both improvement and stabilization of symptoms, across multiple outcomes, and thus provides a clinically important treatment benefit for patients with moderate-to-severe AD. SN - 1064-7481 UR - https://www.unboundmedicine.com/medline/citation/16670247/A_responder_analysis_of_memantine_treatment_in_patients_with_Alzheimer_disease_maintained_on_donepezil_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1064-7481(12)60699-X DB - PRIME DP - Unbound Medicine ER -