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A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design
BACKGROUND: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PS...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
S. Karger AG
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3919431/ https://www.ncbi.nlm.nih.gov/pubmed/24516413 http://dx.doi.org/10.1159/000357122 |
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author | Guekht, Alla Skoog, Ingmar Korczyn, Amos D. Zakharov, Vladimir Eeg, Martin Vigonius, Ulf |
author_facet | Guekht, Alla Skoog, Ingmar Korczyn, Amos D. Zakharov, Vladimir Eeg, Martin Vigonius, Ulf |
author_sort | Guekht, Alla |
collection | PubMed |
description | BACKGROUND: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI) and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. DESIGN: ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited) with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke), after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally) or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10); National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. CONCLUSION: There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI. |
format | Online Article Text |
id | pubmed-3919431 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | S. Karger AG |
record_format | MEDLINE/PubMed |
spelling | pubmed-39194312014-02-10 A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design Guekht, Alla Skoog, Ingmar Korczyn, Amos D. Zakharov, Vladimir Eeg, Martin Vigonius, Ulf Dement Geriatr Cogn Dis Extra Original Research Article BACKGROUND: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI) and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. DESIGN: ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited) with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke), after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally) or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10); National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. CONCLUSION: There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI. S. Karger AG 2013-12-14 /pmc/articles/PMC3919431/ /pubmed/24516413 http://dx.doi.org/10.1159/000357122 Text en Copyright © 2013 by S. Karger AG, Basel http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article licensed under the terms of the Creative Commons Attribution-NonCommercial 3.0 Unported license (CC BY-NC) (www.karger.com/OA-license), applicable to the online version of the article only. Users may download, print and share this work on the Internet for noncommercial purposes only, provided the original work is properly cited, and a link to the original work on http://www.karger.com and the terms of this license are included in any shared versions. |
spellingShingle | Original Research Article Guekht, Alla Skoog, Ingmar Korczyn, Amos D. Zakharov, Vladimir Eeg, Martin Vigonius, Ulf A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title | A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title_full | A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title_fullStr | A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title_full_unstemmed | A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title_short | A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design |
title_sort | randomised, double-blind, placebo-controlled trial of actovegin in patients with post-stroke cognitive impairment: artemida study design |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3919431/ https://www.ncbi.nlm.nih.gov/pubmed/24516413 http://dx.doi.org/10.1159/000357122 |
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