Efficacy and safety of galantamine in patients with dementia with Lewy bodies: a 24-week open-label study. Edwards, K., Royall, D., Hershey, L., Lichter, D., Hake, A., Farlow, M., Pasquier, F., & Johnson, S. Dementia and Geriatric Cognitive Disorders, 23(6):401–405, 2007. doi abstract bibtex BACKGROUND: Dementia with Lewy bodies (DLB) is a common dementia of the elderly. A significant cholinergic deficit has been demonstrated that may be responsive to treatment by cholinesterase inhibitors (ChEIs). METHODS: A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB. RESULTS: This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. Adverse events were generally mild and transient. CONCLUSION: Galantamine appears to be an effective and safe therapy for patients with DLB.
@article{edwards_efficacy_2007,
title = {Efficacy and safety of galantamine in patients with dementia with {Lewy} bodies: a 24-week open-label study},
volume = {23},
issn = {1420-8008},
shorttitle = {Efficacy and safety of galantamine in patients with dementia with {Lewy} bodies},
doi = {10.1159/000101512},
abstract = {BACKGROUND: Dementia with Lewy bodies (DLB) is a common dementia of the elderly. A significant cholinergic deficit has been demonstrated that may be responsive to treatment by cholinesterase inhibitors (ChEIs).
METHODS: A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB.
RESULTS: This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. Adverse events were generally mild and transient.
CONCLUSION: Galantamine appears to be an effective and safe therapy for patients with DLB.},
language = {eng},
number = {6},
journal = {Dementia and Geriatric Cognitive Disorders},
author = {Edwards, Keith and Royall, Donald and Hershey, Linda and Lichter, David and Hake, Ann and Farlow, Martin and Pasquier, Florence and Johnson, Stewart},
year = {2007},
pmid = {17409748},
keywords = {Aged, Humans, Dementia, Female, Male, Middle Aged, Neurologic Examination, Neuropsychological Tests, Aged, 80 and over, Treatment Outcome, Mental Status Schedule, Behavioral Symptoms, Cholinesterase Inhibitors, Galantamine, Lewy Body Disease, Dose-Response Relationship, Drug, Hallucinations, Parkinsonian Disorders},
pages = {401--405}
}
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METHODS: A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB. RESULTS: This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. Adverse events were generally mild and transient. CONCLUSION: Galantamine appears to be an effective and safe therapy for patients with DLB.","language":"eng","number":"6","journal":"Dementia and Geriatric Cognitive Disorders","author":[{"propositions":[],"lastnames":["Edwards"],"firstnames":["Keith"],"suffixes":[]},{"propositions":[],"lastnames":["Royall"],"firstnames":["Donald"],"suffixes":[]},{"propositions":[],"lastnames":["Hershey"],"firstnames":["Linda"],"suffixes":[]},{"propositions":[],"lastnames":["Lichter"],"firstnames":["David"],"suffixes":[]},{"propositions":[],"lastnames":["Hake"],"firstnames":["Ann"],"suffixes":[]},{"propositions":[],"lastnames":["Farlow"],"firstnames":["Martin"],"suffixes":[]},{"propositions":[],"lastnames":["Pasquier"],"firstnames":["Florence"],"suffixes":[]},{"propositions":[],"lastnames":["Johnson"],"firstnames":["Stewart"],"suffixes":[]}],"year":"2007","pmid":"17409748","keywords":"Aged, Humans, Dementia, Female, Male, Middle Aged, Neurologic Examination, Neuropsychological Tests, Aged, 80 and over, Treatment Outcome, Mental Status Schedule, Behavioral Symptoms, Cholinesterase Inhibitors, Galantamine, Lewy Body Disease, Dose-Response Relationship, Drug, Hallucinations, Parkinsonian Disorders","pages":"401–405","bibtex":"@article{edwards_efficacy_2007,\n\ttitle = {Efficacy and safety of galantamine in patients with dementia with {Lewy} bodies: a 24-week open-label study},\n\tvolume = {23},\n\tissn = {1420-8008},\n\tshorttitle = {Efficacy and safety of galantamine in patients with dementia with {Lewy} bodies},\n\tdoi = {10.1159/000101512},\n\tabstract = {BACKGROUND: Dementia with Lewy bodies (DLB) is a common dementia of the elderly. A significant cholinergic deficit has been demonstrated that may be responsive to treatment by cholinesterase inhibitors (ChEIs).\nMETHODS: A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB.\nRESULTS: This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. 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