Document Detail

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study.
MedLine Citation:
PMID:  19949165     Owner:  NLM     Status:  MEDLINE    
Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% of participants in the donepezil/donepezil group and 62.3% in the placebo/donepezil group experienced an AE, with the most frequent treatment-emergent AEs being diarrhea, muscle spasms, insomnia, and nausea. Most were mild to moderate in severity and were more common in the first several weeks after treatment initiation. More participants in the placebo/donepezil group (22.1%) discontinued donepezil due to an AE compared with the donepezil/donepezil group (10.3%). These findings support the safety of donepezil in patients with aMCI. When compared with other studies, however, the data suggest that patients with Alzheimer's tolerate donepezil better than patients with MCI.
Rachelle S Doody; Steven Ferris; Stephen Salloway; Yijun Sun; Robert Goldman; Yikang Xu; Jeff Gao; Anita K Murthy
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-30
Journal Detail:
Title:  American journal of Alzheimer's disease and other dementias     Volume:  25     ISSN:  1938-2731     ISO Abbreviation:  Am J Alzheimers Dis Other Demen     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-04     Completed Date:  2010-07-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101082834     Medline TA:  Am J Alzheimers Dis Other Demen     Country:  United States    
Other Details:
Languages:  eng     Pagination:  155-9     Citation Subset:  IM    
Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, 6550 Fannin, Houston, TX 77030, USA.
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MeSH Terms
Aged, 80 and over
Amnesia / drug therapy*,  psychology
Cholinesterase Inhibitors / administration & dosage,  adverse effects*
Cognition Disorders / drug therapy*,  psychology
Diarrhea / chemically induced
Double-Blind Method
Follow-Up Studies
Indans / administration & dosage,  adverse effects*
Middle Aged
Nausea / chemically induced
Neuropsychological Tests
Piperidines / administration & dosage,  adverse effects*
Psychiatric Status Rating Scales
Severity of Illness Index
Sleep Initiation and Maintenance Disorders / chemically induced
Spasm / chemically induced
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Cholinesterase Inhibitors; 0/Indans; 0/Piperidines; 120011-70-3/donepezil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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