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Background <p>Focused ultrasound (FUS) has emerged as a non-invasive approach to transiently open the blood–brain barrier (BBB) and facilitate therapeutic delivery in Alzheimer’s disease (AD). This systematic review evaluates current clinical evidence regarding the feasibility, safety, and reported biological and clinical outcomes of FUS-mediated BBB opening.</p> Method <p>A systematic search of PubMed, Scopus, and Web of Science was conducted in accordance with PRISMA 2020 guidelines and supplemented by Google Scholar. Human clinical studies employing FUS-induced BBB opening in AD were included. Risk of bias was assessed using the ROBINS-I tool for non-randomized studies.</p> Results <p>From an initial screening of 587 records, 27 studies met the inclusion criteria. Across these studies, FUS-mediated BBB opening was generally feasible and well tolerated, with no reports of irreversible procedure-related adverse events. Reported adverse effects were typically mild and transient, including localized headache, fatigue, or imaging-detected edema. Exploratory findings included heterogeneous changes in cognitive measures and regional amyloid-β biomarkers assessed by neuroimaging or cerebrospinal fluid analysis. Substantial variability in study design, target regions, sonication parameters, and outcome measures limited quantitative synthesis and definitive interpretation.</p> Conclusion <p>Current clinical evidence supports the short-term feasibility and safety of FUS-mediated BBB opening in AD. However, the available data remain preliminary, and well-designed randomized controlled trials with larger cohorts, standardized imaging and cognitive endpoints, and longer follow-up are required to determine therapeutic efficacy and sustained clinical benefit.</p>

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Ultrasound-induced blood–brain barrier opening in Alzheimer’s disease: a systematic review of clinical studies

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月2日

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  • Nafise Niknam,
  • Neda Songhori,
  • Negar Nekahi,
  • Melika Kavian,
  • Farbod Khosravi,
  • Atousa Moghadam Fard,
  • Yeganeh Moshiri,
  • Nazanin Haghshenas,
  • Mostafa Heidari Sadegh,
  • Paria Torabi

摘要

Background

Focused ultrasound (FUS) has emerged as a non-invasive approach to transiently open the blood–brain barrier (BBB) and facilitate therapeutic delivery in Alzheimer’s disease (AD). This systematic review evaluates current clinical evidence regarding the feasibility, safety, and reported biological and clinical outcomes of FUS-mediated BBB opening.

Method

A systematic search of PubMed, Scopus, and Web of Science was conducted in accordance with PRISMA 2020 guidelines and supplemented by Google Scholar. Human clinical studies employing FUS-induced BBB opening in AD were included. Risk of bias was assessed using the ROBINS-I tool for non-randomized studies.

Results

From an initial screening of 587 records, 27 studies met the inclusion criteria. Across these studies, FUS-mediated BBB opening was generally feasible and well tolerated, with no reports of irreversible procedure-related adverse events. Reported adverse effects were typically mild and transient, including localized headache, fatigue, or imaging-detected edema. Exploratory findings included heterogeneous changes in cognitive measures and regional amyloid-β biomarkers assessed by neuroimaging or cerebrospinal fluid analysis. Substantial variability in study design, target regions, sonication parameters, and outcome measures limited quantitative synthesis and definitive interpretation.

Conclusion

Current clinical evidence supports the short-term feasibility and safety of FUS-mediated BBB opening in AD. However, the available data remain preliminary, and well-designed randomized controlled trials with larger cohorts, standardized imaging and cognitive endpoints, and longer follow-up are required to determine therapeutic efficacy and sustained clinical benefit.