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Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial.
Dement Geriatr Cogn Disord 2008; 25(5):399-407DG

Abstract

BACKGROUND/AIMS

A 24-week, randomized, parallel-group, double-blind placebo-controlled study was conducted to evaluate the efficacy and tolerability of donepezil in severe Alzheimer's disease (AD).

METHODS

Patients with severe AD (Mini-Mental State Examination score 1-12; modified Hachinski Ischemic Score < or =6; Functional Assessment Staging > or =6) were enrolled in this study in Japan. A total of 325 patients were randomized to donepezil 5 mg/day (n = 110), donepezil 10 mg/day (n = 103) or placebo (n = 112). Primary outcome measures were change from baseline to endpoint in the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus) at the endpoint visit.

RESULTS

Donepezil 5 mg/day and 10 mg/day were significantly superior to placebo on the SIB, with a least-squares mean treatment difference of 6.7 and 9.0, respectively (p < 0.001 compared with placebo). CIBIC-plus analyses showed significant differences in favor of donepezil 10 mg/day over placebo at endpoint (p = 0.003). A statistically significant dose-response relationship was demonstrated with the SIB and CIBIC-plus. Donepezil was well tolerated.

CONCLUSION

This study confirmed the effectiveness of donepezil 10 mg/day in patients with severe AD and demonstrated a significant dose-response relationship. Donepezil at dosages of both 5 mg/day and 10 mg/day is safe and well tolerated in Japanese patients with severe AD.

Authors+Show Affiliations

Dementia Interventional Research Group, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan. ahomma@tmig.or.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18391486

Citation

Homma, Akira, et al. "Donepezil Treatment of Patients With Severe Alzheimer's Disease in a Japanese Population: Results From a 24-week, Double-blind, Placebo-controlled, Randomized Trial." Dementia and Geriatric Cognitive Disorders, vol. 25, no. 5, 2008, pp. 399-407.
Homma A, Imai Y, Tago H, et al. Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dement Geriatr Cogn Disord. 2008;25(5):399-407.
Homma, A., Imai, Y., Tago, H., Asada, T., Shigeta, M., Iwamoto, T., ... Ohbayashi, T. (2008). Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dementia and Geriatric Cognitive Disorders, 25(5), pp. 399-407. doi:10.1159/000122961.
Homma A, et al. Donepezil Treatment of Patients With Severe Alzheimer's Disease in a Japanese Population: Results From a 24-week, Double-blind, Placebo-controlled, Randomized Trial. Dement Geriatr Cogn Disord. 2008;25(5):399-407. PubMed PMID: 18391486.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. AU - Homma,Akira, AU - Imai,Yukimichi, AU - Tago,Hisao, AU - Asada,Takashi, AU - Shigeta,Masahiro, AU - Iwamoto,Toshihiko, AU - Takita,Masashi, AU - Arimoto,Itaru, AU - Koma,Hiroshi, AU - Ohbayashi,Toshio, Y1 - 2008/04/03/ PY - 2007/12/20/accepted PY - 2008/4/9/pubmed PY - 2008/6/18/medline PY - 2008/4/9/entrez SP - 399 EP - 407 JF - Dementia and geriatric cognitive disorders JO - Dement Geriatr Cogn Disord VL - 25 IS - 5 N2 - BACKGROUND/AIMS: A 24-week, randomized, parallel-group, double-blind placebo-controlled study was conducted to evaluate the efficacy and tolerability of donepezil in severe Alzheimer's disease (AD). METHODS: Patients with severe AD (Mini-Mental State Examination score 1-12; modified Hachinski Ischemic Score < or =6; Functional Assessment Staging > or =6) were enrolled in this study in Japan. A total of 325 patients were randomized to donepezil 5 mg/day (n = 110), donepezil 10 mg/day (n = 103) or placebo (n = 112). Primary outcome measures were change from baseline to endpoint in the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus) at the endpoint visit. RESULTS: Donepezil 5 mg/day and 10 mg/day were significantly superior to placebo on the SIB, with a least-squares mean treatment difference of 6.7 and 9.0, respectively (p < 0.001 compared with placebo). CIBIC-plus analyses showed significant differences in favor of donepezil 10 mg/day over placebo at endpoint (p = 0.003). A statistically significant dose-response relationship was demonstrated with the SIB and CIBIC-plus. Donepezil was well tolerated. CONCLUSION: This study confirmed the effectiveness of donepezil 10 mg/day in patients with severe AD and demonstrated a significant dose-response relationship. Donepezil at dosages of both 5 mg/day and 10 mg/day is safe and well tolerated in Japanese patients with severe AD. SN - 1421-9824 UR - https://www.unboundmedicine.com/medline/citation/18391486/Donepezil_treatment_of_patients_with_severe_Alzheimer's_disease_in_a_Japanese_population:_results_from_a_24_week_double_blind_placebo_controlled_randomized_trial_ L2 - https://www.karger.com?DOI=10.1159/000122961 DB - PRIME DP - Unbound Medicine ER -