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Donepezil preserves cognition and global function in patients with severe Alzheimer disease.
Neurology 2007; 69(5):459-69Neur

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.

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.caNo 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

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 -