A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease-- rivastigmine patch versus capsule.
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| Title: | A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease-- rivastigmine patch versus capsule. |
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| Authors: | Winblad B (AUTHOR), Cummings J (AUTHOR), Andreasen N (AUTHOR), Grossberg G (AUTHOR), Onofrj M (AUTHOR), Sadowsky C (AUTHOR), Zechner S (AUTHOR), Nagel J (AUTHOR), Lane R (AUTHOR) |
| Source: | International Journal of Geriatric Psychiatry. May2007, Vol. 22 Issue 5, p456-467. 12p. |
| Abstract: | OBJECTIVES: To compare the efficacy, safety and tolerability of a novel rivastigmine transdermal patch with conventional rivastigmine capsules and placebo in patients with Alzheimer's disease (AD). METHODS: In this 24-week, multicenter, double-blind, double-dummy, placebo- and active-controlled trial, patients with probable AD were randomized to one of four treatment groups: 12 mg/day rivastigmine capsules; 10 cm(2) (9.5 mg/24 h) rivastigmine patch; 20 cm(2) (17.4 mg/24 h) rivastigmine patch; or placebo. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (ADCS-CGIC). RESULTS: One thousand one hundred and ninety five AD patients from 21 countries participated in the study. Treatment differences (vs placebo) on the ADAS-Cog at Week 24 in 10 cm(2) patch, 20 cm(2) patch and capsule groups were 1.6 (p = 0.005), 2.6 (p < 0.001) and 1.6 (p = 0.003). Treatment differences on the ADCS-CGIC were 0.3 (p = 0.01), 0.2 (p = 0.054) and 0.3 (p = 0.009). Comparison between the 10 cm(2) patch and the capsule revealed non-inferiority. Rates of nausea in the 10 cm(2) patch and capsule groups were 7.2% and 23.1%, respectively; rates of vomiting were 6.2% and 17.0%, respectively. Moderate or severe skin irritation occurred in |
| Copyright of International Journal of Geriatric Psychiatry is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 106189360 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease-- rivastigmine patch versus capsule. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Winblad+B%22">Winblad B</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cummings+J%22">Cummings J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Andreasen+N%22">Andreasen N</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grossberg+G%22">Grossberg G</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Onofrj+M%22">Onofrj M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sadowsky+C%22">Sadowsky C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zechner+S%22">Zechner S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nagel+J%22">Nagel J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lane+R%22">Lane R</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22International+Journal+of+Geriatric+Psychiatry%22">International Journal of Geriatric Psychiatry</searchLink>. May2007, Vol. 22 Issue 5, p456-467. 12p. – Name: Abstract Label: Abstract Group: Ab Data: OBJECTIVES: To compare the efficacy, safety and tolerability of a novel rivastigmine transdermal patch with conventional rivastigmine capsules and placebo in patients with Alzheimer's disease (AD). METHODS: In this 24-week, multicenter, double-blind, double-dummy, placebo- and active-controlled trial, patients with probable AD were randomized to one of four treatment groups: 12 mg/day rivastigmine capsules; 10 cm(2) (9.5 mg/24 h) rivastigmine patch; 20 cm(2) (17.4 mg/24 h) rivastigmine patch; or placebo. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (ADCS-CGIC). RESULTS: One thousand one hundred and ninety five AD patients from 21 countries participated in the study. Treatment differences (vs placebo) on the ADAS-Cog at Week 24 in 10 cm(2) patch, 20 cm(2) patch and capsule groups were 1.6 (p = 0.005), 2.6 (p < 0.001) and 1.6 (p = 0.003). Treatment differences on the ADCS-CGIC were 0.3 (p = 0.01), 0.2 (p = 0.054) and 0.3 (p = 0.009). Comparison between the 10 cm(2) patch and the capsule revealed non-inferiority. Rates of nausea in the 10 cm(2) patch and capsule groups were 7.2% and 23.1%, respectively; rates of vomiting were 6.2% and 17.0%, respectively. Moderate or severe skin irritation occurred in </=10% patients across the four patch sizes (5, 10, 15 and 20 cm(2)). CONCLUSIONS: The target dose of 10 cm(2) rivastigmine patch provides efficacy similar to the highest doses of capsules with a superior tolerability profile. The transdermal patch with rivastigmine may offer convenience important to many caregivers and patients. Copyright (c) 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of International Journal of Geriatric Psychiatry is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/gps.1788 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 12 StartPage: 456 Titles: – TitleFull: A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease-- rivastigmine patch versus capsule. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Winblad B – PersonEntity: Name: NameFull: Cummings J – PersonEntity: Name: NameFull: Andreasen N – PersonEntity: Name: NameFull: Grossberg G – PersonEntity: Name: NameFull: Onofrj M – PersonEntity: Name: NameFull: Sadowsky C – PersonEntity: Name: NameFull: Zechner S – PersonEntity: Name: NameFull: Nagel J – PersonEntity: Name: NameFull: Lane R IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 05 Text: May2007 Type: published Y: 2007 Identifiers: – Type: issn-print Value: 08856230 Numbering: – Type: volume Value: 22 – Type: issue Value: 5 Titles: – TitleFull: International Journal of Geriatric Psychiatry Type: main |
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