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Neurology
Protocol
Effect of antiamyloid-β drugs on Alzheimer’s disease: study protocol for a systematic review and meta-analysis
  1. Diyang Lyu1,
  2. Yuqing Shi1,
  3. Xuanxin Lyu2
  1. 1Capital Medical University, Beijing, China
  2. 2Neurological Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University, Beijing, China
  1. Correspondence to Dr Xuanxin Lyu; lvxvanxin{at}163.com

Abstract

Introduction Alzheimer’s disease (AD) is a neurodegenerative disease with a complex aetiology involving multiple targets and pathways. With the continuous growth of the ageing population, the burden of AD is increasing year by year. However, there has not been new drug approved for over a decade. In addition, the efficacy of memantine and cholinesterase inhibitors is not satisfactory. As amyloid-β (Aβ) is regarded as the core pathological change and the trigger mechanism of AD, anti-Aβ therapy may be an effective therapy. In recent years, a lot of clinical trials have been carried out in this field, but the results have not been well summarised and analysed.

Methods and analysis In this study, we will study the effect of anti-Aβ antibodies versus placebo on the clinical efficacy, biomarkers, neuroimaging and safety in different stages of AD, as well as the factors that may affect the efficacy. Drugs that only target the existing Aβ are regarded as anti-Aβ antibodies. Following electronic databases will be searched from inception to April 2021: Medline-Ovid, EMBase-Ovid, Cochrane Central and clinical trial registration platform ClinicalTrials.gov. After identifying eligible studies through screening title, abstract and read full text of each retrieved literature, we will contact the correspondence authors for additional information and grey literatures. To get more reliable results, random effect model will be conducted for meta-analysis and analysis of subgroups or subsets. Funnel plot, Egger’s test and sensitivity analysis will be conducted to explore potential heterogeneity. Meta-regression will be conducted to identify the factors that may affect clinical efficacy. Evidence quality assessment and trial sequential analysis will be conducted to assess the quality of evidence and confirm the reliability of the results in this study.

Ethics and discussion This study does not require formal ethical approval. The findings will be submitted to a peer-review journal.

PROSPERO registration number CRD42020202370.

  • dementia
  • clinical trials
  • therapeutics
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-048453

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    Footnotes

    • DL and YS contributed equally.

    • Contributors DL and XL designed this study. DL and YS developed the search strategy and the data extraction list. DL drafted the manuscript. YS and XL revised the manuscript and provided methodological perspectives. DL and YS will search and screen literatures and perform data extraction. DL will assess the quality of included studies and conduct data analyses. All authors read and approved the final manuscript.

    • Funding This work was supported by The Scientific Research Fund of Beijing Rehabilitation Hospital, Capital Medical University. The funders had no role in developing this protocol.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.