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Donepezil preserves cognition and global function in patients with severe Alzheimer disease.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of donepezil for severe Alzheimer disease (AD).

METHODS

Patients with severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores > or =6) were enrolled in this multinational, double-blind, placebo-controlled trial at 98 sites. Patients were randomized to donepezil 10 mg daily or placebo for 24 weeks. Primary endpoints were the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). Secondary endpoints included the MMSE, the Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev), the Neuropsychiatric Inventory (NPI), the Caregiver Burden Questionnaire (CBQ), and the Resource Utilization for Severe Alzheimer Disease Patients (RUSP). Efficacy analyses were performed in the intent-to-treat (ITT) population using last post-baseline observation carried forward (LOCF). Safety assessments were performed for patients receiving > or =1 dose of donepezil or placebo.

RESULTS

Patients were randomized to donepezil (n = 176) or placebo (n = 167). Donepezil was superior to placebo on SIB score change from baseline to endpoint (least squares mean difference 5.32; p = 0.0001). CIBIC-Plus and MMSE scores favored donepezil at endpoint (p = 0.0473 and p = 0.0267). Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP. Adverse events reported were consistent with the known cholinergic effects of donepezil and with the safety profile in patients with mild to moderate AD.

CONCLUSION

Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function.

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  • Authors+Show Affiliations

    ,

    Division of Neurology, Department of Medicine and Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada. sandra.black@sunnybrook.ca

    , , , , , , ,

    Source

    Neurology 69:5 2007 Jul 31 pg 459-69

    MeSH

    Activities of Daily Living
    Aged
    Aged, 80 and over
    Alzheimer Disease
    Caregivers
    Cholinesterase Inhibitors
    Cognition
    Cognition Disorders
    Disease Progression
    Donepezil
    Double-Blind Method
    Female
    Humans
    Indans
    Male
    Middle Aged
    Neuropsychological Tests
    Piperidines
    Placebos
    Recovery of Function
    Severity of Illness Index
    Surveys and Questionnaires
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    17664405

    Citation

    Black, S E., et al. "Donepezil Preserves Cognition and Global Function in Patients With Severe Alzheimer Disease." Neurology, vol. 69, no. 5, 2007, pp. 459-69.
    Black SE, Doody R, Li H, et al. Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology. 2007;69(5):459-69.
    Black, S. E., Doody, R., Li, H., McRae, T., Jambor, K. M., Xu, Y., ... Richardson, S. (2007). Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology, 69(5), pp. 459-69.
    Black SE, et al. Donepezil Preserves Cognition and Global Function in Patients With Severe Alzheimer Disease. Neurology. 2007 Jul 31;69(5):459-69. PubMed PMID: 17664405.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Donepezil preserves cognition and global function in patients with severe Alzheimer disease. AU - Black,S E, AU - Doody,R, AU - Li,H, AU - McRae,T, AU - Jambor,K M, AU - Xu,Y, AU - Sun,Y, AU - Perdomo,C A, AU - Richardson,S, PY - 2007/8/1/pubmed PY - 2007/8/25/medline PY - 2007/8/1/entrez SP - 459 EP - 69 JF - Neurology JO - Neurology VL - 69 IS - 5 N2 - OBJECTIVE: To evaluate the efficacy and safety of donepezil for severe Alzheimer disease (AD). METHODS: Patients with severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores > or =6) were enrolled in this multinational, double-blind, placebo-controlled trial at 98 sites. Patients were randomized to donepezil 10 mg daily or placebo for 24 weeks. Primary endpoints were the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). Secondary endpoints included the MMSE, the Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev), the Neuropsychiatric Inventory (NPI), the Caregiver Burden Questionnaire (CBQ), and the Resource Utilization for Severe Alzheimer Disease Patients (RUSP). Efficacy analyses were performed in the intent-to-treat (ITT) population using last post-baseline observation carried forward (LOCF). Safety assessments were performed for patients receiving > or =1 dose of donepezil or placebo. RESULTS: Patients were randomized to donepezil (n = 176) or placebo (n = 167). Donepezil was superior to placebo on SIB score change from baseline to endpoint (least squares mean difference 5.32; p = 0.0001). CIBIC-Plus and MMSE scores favored donepezil at endpoint (p = 0.0473 and p = 0.0267). Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP. Adverse events reported were consistent with the known cholinergic effects of donepezil and with the safety profile in patients with mild to moderate AD. CONCLUSION: Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/17664405/Donepezil_preserves_cognition_and_global_function_in_patients_with_severe_Alzheimer_disease_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=17664405 DB - PRIME DP - Unbound Medicine ER -