دورية أكاديمية

A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design

التفاصيل البيبلوغرافية
العنوان: A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design
المؤلفون: Alla Guekht, Ingmar Skoog, Amos D. Korczyn, Vladimir Zakharov, Martin Eeg, Ulf Vigonius
المصدر: Dementia and Geriatric Cognitive Disorders Extra, Vol 3, Iss 1, Pp 459-467 (2013)
بيانات النشر: Karger Publishers, 2013.
سنة النشر: 2013
المجموعة: LCC:Neurology. Diseases of the nervous system
LCC:Geriatrics
مصطلحات موضوعية: Stroke, Vascular dementia, Cognitive impairment, Actovegin, Pharmacotherapy, Neurology. Diseases of the nervous system, RC346-429, Geriatrics, RC952-954.6
الوصف: 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.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1664-5464
العلاقة: http://www.karger.com/Article/FullText/357122Test; https://doaj.org/toc/1664-5464Test
DOI: 10.1159/000357122
الوصول الحر: https://doaj.org/article/f7767a54ff674d099f979263aeedec69Test
رقم الانضمام: edsdoj.f7767a54ff674d099f979263aeedec69
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:16645464
DOI:10.1159/000357122