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Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease.

Abstract

OBJECTIVE

To investigate the efficacy and safety of donepezil in a subgroup of patients with Alzheimer's disease (AD) of moderate severity from a previous trial.

METHODS

Two hundred and seven patients with moderate AD (standardized Mini-Mental State Examination [sMMSE] score 10-17) were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patents received either donepezil, 5 mg/day for the first 28 days and 10 mg/day thereafter according to the clinician's judgement (n = 102), or placebo (n = 105). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus) at week 24 using a last observation carried forward (LOCF) analysis.

RESULTS

Baseline patient demographics were similar between treatment groups. Mean age was 74.3 years (range 48-92). Least-squares (LS) mean sMMSE scores at baseline were 13.6 +/- 0.3 for the donepezil group and 13.9 +/- 0.3 for the placebo group. LS mean CIBIC-plus scores for donepezil-treated patients were improved from, or close to, baseline severity at all visits, and were significantly different from placebo at weeks 8, 12, 18, and 24 (week 24 LOCF mean difference = 0.53, p = 0.0003). LS mean change from baseline scores on the sMMSE and Severe Impairment Battery (SIB) for the donepezil group improved throughout the study, and were significantly different from placebo at each visit for the sMMSE (week 24 LOCF mean difference = 2.06, p = 0.0002) and from week 8 for the SIB (week 24 LOCF mean difference = -4.44, p = 0.0026). LS mean change scores on the Disability Assessment for Dementia remained at or above baseline levels throughout the study for the donepezil group, while the placebo group showed a steady decline; treatment differences were significant at each visit (week 24 LOCF mean difference = -9.25, p < 0.0001). LS mean change scores on the Neuropsychiatric Inventory 12-item total improved throughout the study for the donepezil group and were significantly different from placebo at weeks 4 and 24 (week 24 LOCF mean difference = 5.92, p = 0.0022). Eighty-one per cent of donepezil-treated and 89% of placebo-treated patients completed the trial, with 9% and 5%, respectively, discontinuing due to adverse events (AEs). Eighty-two per cent of donepezil-treated and 80% of placebo-treated patients experienced AEs, the majority of which were rated mild in severity and, in general, were similar between treatment groups.

CONCLUSION

The significant treatment responses observed with donepezil in these patients reinforce the findings from earlier studies that show donepezil to have important benefits, compared wih placebo, across functional, cognitive, and behavioral symptoms, with good tolerability, in patients with AD of moderate severity.

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  • Authors+Show Affiliations

    ,

    serge.gauthier@mcgill.ca

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    MeSH

    Activities of Daily Living
    Aged
    Aged, 80 and over
    Alzheimer Disease
    Behavior
    Cognition
    Donepezil
    Double-Blind Method
    Female
    Humans
    Indans
    Male
    Middle Aged
    Neuropsychological Tests
    Nootropic Agents
    Piperidines
    Severity of Illness Index

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    12442882

    Citation

    Gauthier, S, et al. "Functional, Cognitive and Behavioral Effects of Donepezil in Patients With Moderate Alzheimer's Disease." Current Medical Research and Opinion, vol. 18, no. 6, 2002, pp. 347-54.
    Gauthier S, Feldman H, Hecker J, et al. Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease. Curr Med Res Opin. 2002;18(6):347-54.
    Gauthier, S., Feldman, H., Hecker, J., Vellas, B., Emir, B., & Subbiah, P. (2002). Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease. Current Medical Research and Opinion, 18(6), pp. 347-54.
    Gauthier S, et al. Functional, Cognitive and Behavioral Effects of Donepezil in Patients With Moderate Alzheimer's Disease. Curr Med Res Opin. 2002;18(6):347-54. PubMed PMID: 12442882.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease. AU - Gauthier,S, AU - Feldman,H, AU - Hecker,J, AU - Vellas,B, AU - Emir,B, AU - Subbiah,P, AU - ,, PY - 2002/11/22/pubmed PY - 2003/3/21/medline PY - 2002/11/22/entrez SP - 347 EP - 54 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 18 IS - 6 N2 - OBJECTIVE: To investigate the efficacy and safety of donepezil in a subgroup of patients with Alzheimer's disease (AD) of moderate severity from a previous trial. METHODS: Two hundred and seven patients with moderate AD (standardized Mini-Mental State Examination [sMMSE] score 10-17) were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patents received either donepezil, 5 mg/day for the first 28 days and 10 mg/day thereafter according to the clinician's judgement (n = 102), or placebo (n = 105). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus) at week 24 using a last observation carried forward (LOCF) analysis. RESULTS: Baseline patient demographics were similar between treatment groups. Mean age was 74.3 years (range 48-92). Least-squares (LS) mean sMMSE scores at baseline were 13.6 +/- 0.3 for the donepezil group and 13.9 +/- 0.3 for the placebo group. LS mean CIBIC-plus scores for donepezil-treated patients were improved from, or close to, baseline severity at all visits, and were significantly different from placebo at weeks 8, 12, 18, and 24 (week 24 LOCF mean difference = 0.53, p = 0.0003). LS mean change from baseline scores on the sMMSE and Severe Impairment Battery (SIB) for the donepezil group improved throughout the study, and were significantly different from placebo at each visit for the sMMSE (week 24 LOCF mean difference = 2.06, p = 0.0002) and from week 8 for the SIB (week 24 LOCF mean difference = -4.44, p = 0.0026). LS mean change scores on the Disability Assessment for Dementia remained at or above baseline levels throughout the study for the donepezil group, while the placebo group showed a steady decline; treatment differences were significant at each visit (week 24 LOCF mean difference = -9.25, p < 0.0001). LS mean change scores on the Neuropsychiatric Inventory 12-item total improved throughout the study for the donepezil group and were significantly different from placebo at weeks 4 and 24 (week 24 LOCF mean difference = 5.92, p = 0.0022). Eighty-one per cent of donepezil-treated and 89% of placebo-treated patients completed the trial, with 9% and 5%, respectively, discontinuing due to adverse events (AEs). Eighty-two per cent of donepezil-treated and 80% of placebo-treated patients experienced AEs, the majority of which were rated mild in severity and, in general, were similar between treatment groups. CONCLUSION: The significant treatment responses observed with donepezil in these patients reinforce the findings from earlier studies that show donepezil to have important benefits, compared wih placebo, across functional, cognitive, and behavioral symptoms, with good tolerability, in patients with AD of moderate severity. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/12442882/Functional_cognitive_and_behavioral_effects_of_donepezil_in_patients_with_moderate_Alzheimer's_disease_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079902125001029 DB - PRIME DP - Unbound Medicine ER -