Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach.

IF 4.6 2区 医学 Q1 GERIATRICS & GERONTOLOGY
Jeffrey L Cummings, Kate Zhong, Clive Ballard, Mary Sano, Jacobo Mintzer
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引用次数: 0

Abstract

Neuropsychiatric syndromes (NPS) such as agitation, psychosis, apathy, and irritability are among the most disabling features of major and mild neurocognitive disorders including Alzheimer's disease, other neurodegenerative disorders (NDD), and vascular cognitive impairment. Clinical trial methodologies for the treatment of these syndromes are evolving and the first agents to reduce NPS severity has been approved. Biomarkers are rapidly becoming available to guide clinical trial decision-making. Biomarkers can confirm the diagnosis of Alzheimer's disease and are playing a larger role in non-Alzheimer trials. The Consolidated Standards for Reporting Trials (CONSORT) specify the elements of clinical trials that must be reported when clinical trials are published. These criteria provide conventions for uniform reporting of all key aspects of a clinical trial and facilitate comparisons across trials. We describe best practices for clinical trials of NPS including research definitions of the NDD, use of biomarkers to support clinical diagnosis, research criteria for NPS, use of rating scales to define the severity of NPS at baseline and as endpoints for the clinical trial, and approaches to data analysis of specific interest in NPS trials. Standards for describing the limitations of trials and their generalizability are provided. The goal is to inform planning and reporting of NPS trials including the use of biomarkers based on CONSORT guidelines for best trial practices.

重度和轻度神经认知障碍患者神经精神综合征的临床试验:基于联合体的方法。
神经精神综合征(NPS),如躁动、精神病、冷漠和易怒,是严重和轻度神经认知障碍(包括阿尔茨海默病、其他神经退行性疾病(NDD)和血管性认知障碍)的最致残特征。治疗这些综合征的临床试验方法正在不断发展,第一批降低NPS严重程度的药物已获得批准。生物标记物正迅速成为指导临床试验决策的工具。生物标志物可以确认阿尔茨海默病的诊断,并在非阿尔茨海默病的试验中发挥更大的作用。临床试验综合报告标准(CONSORT)规定了临床试验发表时必须报告的临床试验要素。这些标准为统一报告临床试验的所有关键方面提供了惯例,并促进了试验之间的比较。我们描述了NPS临床试验的最佳实践,包括NDD的研究定义,支持临床诊断的生物标志物的使用,NPS的研究标准,在基线和临床试验终点使用评级量表来定义NPS的严重程度,以及NPS试验中特定兴趣的数据分析方法。提供了描述试验的局限性及其普遍性的标准。目标是为NPS试验的规划和报告提供信息,包括根据CONSORT最佳试验实践指南使用生物标志物。
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来源期刊
International psychogeriatrics
International psychogeriatrics 医学-精神病学
CiteScore
9.10
自引率
8.60%
发文量
217
审稿时长
3-6 weeks
期刊介绍: A highly respected, multidisciplinary journal, International Psychogeriatrics publishes high quality original research papers in the field of psychogeriatrics. The journal aims to be the leading peer reviewed journal dealing with all aspects of the mental health of older people throughout the world. Circulated to over 1,000 members of the International Psychogeriatric Association, International Psychogeriatrics also features important editorials, provocative debates, literature reviews, book reviews and letters to the editor.
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