Effectiveness and Safety of Bu Shen Kai Qiao Fang in the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Prospective, Real-World Clinical Trial

ZeYu Xu; Ou Li; YaTing Liang; ZhiBing Wu; Jiamei Xu; Ling Wang; Ling Li; YongNing Sun

doi:10.2147/IJGM.S418700

Effectiveness and Safety of Bu Shen Kai Qiao Fang in the Treatment of Alzheimer's Disease: Study Protocol for a Multicenter, Prospective, Real-World Clinical Trial

Int J Gen Med. 2023 Jun 17:16:2573-2583. doi: 10.2147/IJGM.S418700. eCollection 2023.

Authors

ZeYu Xu^#¹, Ou Li^#¹, YaTing Liang^#¹, ZhiBing Wu², Jiamei Xu², Ling Wang³, Ling Li³, YongNing Sun¹

Affiliations

¹ Department of Brain and Mental Disease, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, ShangHai, 200040, People's Republic of China.
² Department of Encephalopathy, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, People's Republic of China.
³ Department of Geriatrics, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, 710003, People's Republic of China.

^# Contributed equally.

Abstract

Background: Alzheimer's disease (AD) is a common degenerative disease of the nervous system with serious impact on quality of life of patients and their families. With an aging population, AD has become a major public health problem in China and worldwide. However, the physiological and pathological mechanisms of AD have not been fully elucidated, and there is a lack of effective prevention and clinical treatment methods. Many studies have found that traditional Chinese medicine (TCM) has a good therapeutic effect on cognitive function in AD patients. Bu Shen Kai Qiao Fang (BSKQF) is one such Chinese herbal preparation used in the treatment of AD. We designed a protocol for a real-world clinical study of BSKQF combined with Donepezil hydrochloride (DH) to evaluate the efficacy and safety of this approach in the treatment of AD patients.

Methods: This is a protocol for a real-world, multicenter, prospective, observational cohort study. The study will recruit 860 AD patients from four hospitals across China. Equal numbers of patients will be treated with BSKQF and DH or with DH only. The criteria for grouping are based primarily on patient preference. Outcome measures include scores on the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment Scale (MOCA) and will be recorded at baseline, and at one, two and three months after enrollment. The plasma Aβ42 and plasma Tau levels of participating patients will also be measured by ELISA at baseline and after 3 months of treatment. Safety metrics and adverse events (AEs) of participating patients will be monitored and recorded.

Discussion: This study will evaluate the clinical efficacy and safety of BSKQF in the treatment of AD. The results will provide reliable evidence for the clinical application of BSKQF in the treatment of AD.

Study registration: Trial registration: Chinese Clinical Trial Registry, NO. ChiCTR2000039670, Registered 5 November 2020 https://www.chictr.org.cn/showprojEN.html?proj=63800.

Keywords: Alzheimer’s disease; Aβ42; Bu Shen Kai Qiao Fang; MMSE; MOCA; real-world trial; tau.

Grants and funding

This study is supported by grants from the National Key R&D Program of China (NO. 2018YFC2002504) and the Three-Year Action Plan for Public Health 2020–2022 (Key Discipline Construction-TCM psychology/TCM psychiatry), and Shanghai Municipal Health Commission (GWV-10. 1-XK20). The funding sources have had no role in the study design and will not have a role in the execution, analyses, interpretation of the data, or decision to submit results.