| Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study. | |
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MedLine Citation:
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PMID: 19949165 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Rachelle S Doody; Steven Ferris; Stephen Salloway; Yijun Sun; Robert Goldman; Yikang Xu; Jeff Gao; Anita K Murthy |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-11-30 |
Journal Detail:
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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:
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Created Date: 2010-03-04 Completed Date: 2010-07-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101082834 Medline TA: Am J Alzheimers Dis Other Demen Country: United States |
Other Details:
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Languages: eng Pagination: 155-9 Citation Subset: IM |
Affiliation:
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Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, 6550 Fannin, Houston, TX 77030, USA. rdoody@bcm.tmc.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged 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 Female Follow-Up Studies Humans Indans / administration & dosage, adverse effects* Male 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 |
| Chemical | |
Reg. No./Substance:
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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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