Efficacy, safety, and response predictors of Astragalus in patients with mild to moderate Alzheimer's disease: A study protocol of an assessor-blind, statistician-blind open-label randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-07-28 DOI:10.1016/j.conctc.2024.101339

Yingzhe Cheng , Lin Lin , Peilin Huang , Jiejun Zhang , Xiaodong Pan

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引用次数: 0

Abstract

Background

This pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus membranaceus (AM) for cognition and non-cognition in patients with of mild to moderate Alzheimer's disease complicated with orthostatic hypotension in orthostatic hypotension, elucidate the underlying mechanisms, identify related response predictors, and explore effective drug components.

Methods

This is an add-on, assessor-blinded, parallel, pragmatic, randomized controlled trial. At least 66 adults with mild to moderate Alzheimer's disease (AD) and OH aged 50–85 years will be recruited. Participants will be randomized in a 1:1:1 ratio to receive 24 weeks of routine care or add-on low dose AM or add-on high dose AM group. The primary efficacy outcome will be measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version. Secondary efficacy outcome assessment will include neuropsychological tests, blood pressure, plasma biomarkers, multimodal electroencephalograms, and neuroimaging. Safety outcome measures will include physical examinations, vital signs, electrocardiography, laboratory tests (such as hematologic and blood chemical tests), and adverse event records.

Ethics and dissemination

This trial was approved and supervised by Fujian Medical University Union Hospital (2021KJCX040). Independent results, findings will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number

NCT05647473; ClinicalTrials.gov Identifier.

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黄芪对轻度至中度阿尔茨海默病患者的疗效、安全性和反应预测指标：评估者盲法、统计者盲法开放标签随机对照试验的研究方案

背景这项务实的临床试验旨在确定添加黄芪（AM）治疗轻度至中度阿尔茨海默病并发直立性低血压患者认知和非认知功能障碍的疗效和安全性，阐明其潜在机制，确定相关的反应预测因子，并探索有效的药物成分。将招募至少 66 名患有轻度至中度阿尔茨海默病（AD）和 OH 的 50-85 岁成人。参与者将按1:1:1的比例随机接受为期24周的常规治疗或附加低剂量AM或附加高剂量AM组治疗。主要疗效结果将通过阿尔茨海默病评估量表--认知分量表（中文版）进行测量。次要疗效评估包括神经心理学测试、血压、血浆生物标志物、多模态脑电图和神经影像学检查。伦理与传播本试验由福建医科大学附属协和医院批准并指导（2021KJCX040）。独立结果、研究结果将在同行评审期刊上发表，并在国内和国际会议上展示。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.