不同种类抗阿尔茨海默病药物对认知改善效果的系统评价和网络荟萃分析：III 期临床试验方案。
Effects of different kinds of anti-Alzheimer's disease drugs on cognitive improvement: protocol for a systematic review and network meta-analysis of phase III clinical trials.
机构信息
Capital Medical University, Beijing, 100069, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.
出版信息
Syst Rev. 2022 May 3;11(1):84. doi: 10.1186/s13643-022-01964-x.
BACKGROUND
Alzheimer's disease is a neurodegenerative disease characterized by progressive cognitive decline and dysfunction of independent living ability, with huge economic and healthy burden worldwide. However, there is still a lack of effective long-term drugs to improve cognitive function and reduce or halt disease progression. Phase III clinical trials of anti-AD drugs based on different hypotheses were in the pipeline, and this protocol for a systematic review and meta-analysis aims to determine what is the most effective direction for the development of drugs on cognitive improvement.
METHODS/DESIGN: We will search the following literature databases for eligible studies from inception to December 2021: Ovid MEDLINE, Ovid Embase, PubMed MEDLINE, and Cochrane Central Register of Controlled Trials. Google Scholar, ClinicalTrials.gov registration platform, and the AlzForum website will also be searched for additional studies. Studies will be included irrespective of publication status or language. Phase III clinical trials reporting on the effect of anti-AD drugs on participants with AD will be included. Two independent reviewers will screen the hit articles and identify phase III clinical trials, extract data, and assess the quality of each study individually. The Cochrane Risk of Bias tool 2 (RoB 2) will be used to assess the risk of bias. For each kind of drugs based on the corresponding hypothesis, we will compare the study design and demographic features of the clinical trials and include appropriate studies in the network meta-analysis. The primary outcomes will be the indicators of cognitive improvement. The secondary outcomes will be activities of daily living, neuroimaging changes, biomarkers, and safety. Through network meta-analysis, we will suggest the hypothesis that most likely to improve cognitive function and provide the ranks of all kinds of drugs. We will give recommendation grade of each comparison using the Confidence In Network Meta-Analysis (CINeMa) tool.
DISCUSSION
This study will provide helpful evidence for further drug development and clinical practice for treating Alzheimer's disease.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42021251507.
背景
阿尔茨海默病是一种神经退行性疾病，其特征是认知能力逐渐下降，独立生活能力下降，在全球范围内造成了巨大的经济和健康负担。然而，目前仍然缺乏有效的长期药物来改善认知功能，减缓或阻止疾病的进展。基于不同假说的抗 AD 药物的 III 期临床试验正在进行中，本系统评价和荟萃分析的方案旨在确定药物开发在认知改善方面最有效的方向。
方法/设计：我们将从研究开始到 2021 年 12 月，在以下文献数据库中搜索符合条件的研究：Ovid MEDLINE、Ovid Embase、PubMed MEDLINE 和 Cochrane 中央对照试验注册库。还将搜索 Google Scholar、ClinicalTrials.gov 注册平台和 AlzForum 网站以获取其他研究。无论研究的发表状态或语言如何，都将纳入研究。将纳入报告抗 AD 药物对 AD 患者影响的 III 期临床试验。两名独立的审查员将筛选命中文章，确定 III 期临床试验，提取数据，并单独评估每项研究的质量。Cochrane 偏倚风险工具 2（RoB 2）将用于评估偏倚风险。对于基于相应假说的每一种药物，我们将比较临床试验的研究设计和人口统计学特征，并将适当的研究纳入网络荟萃分析。主要结局指标将是认知改善的指标。次要结局指标将是日常生活活动、神经影像学变化、生物标志物和安全性。通过网络荟萃分析，我们将提出最有可能改善认知功能的假说，并提供各种药物的排名。我们将使用置信网络荟萃分析（CINeMa）工具对每种比较的推荐等级进行评级。
讨论
本研究将为进一步开发治疗阿尔茨海默病的药物和临床实践提供有价值的证据。
系统评价注册
PROSPERO CRD42021251507。
Zotero 插件