Evidence map›Paper›PMID 42228053›Full record

SynthesisAging clinical and experimental research2026

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

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

Abstract readSystematic Review
In one paragraph

Synthesis in Aging clinical and experimental research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Nafise NiknamShiraz University of Medical Sciences, Shiraz, Iran.ORCID http://orcid.org/0009-0007-2071-7673
Neda SonghoriAmirkabir University of Technology, Tehran, Iran. Neda.songhori@gmail.com.ORCID http://orcid.org/0009-0002-3991-7994
Negar NekahiAmirkabir University of Technology, Tehran, Iran.ORCID http://orcid.org/0009-0009-9451-0485
Melika KavianStudents' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0009-0008-0664-8605
Farbod KhosraviShahid Beheshti University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0001-7312-9233
Atousa Moghadam FardDivision of Endocrinology, Metabolism & Diabetes University of Colorado, Colorado, USA.ORCID http://orcid.org/0000-0003-2763-1577
Yeganeh MoshiriFaculty of Psychology and Educational Sciences, Central Tehran Branch, Islamic Azad University, Tehran, Iran.ORCID http://orcid.org/0009-0005-4392-6465
Nazanin HaghshenasDepartment of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.ORCID http://orcid.org/0009-0001-4060-2378
Mostafa Heidari SadeghZabol University of Medical Sciences, Zabol, Iran.ORCID http://orcid.org/0009-0004-5362-4367
Paria TorabiMedical Student, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.ORCID http://orcid.org/0009-0006-9560-3657

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFocused 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.

methodA 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.

resultsFrom 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.

conclusionCurrent 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.

Indexed as

Alzheimer DiseaseBlood-Brain BarrierAmyloid beta-PeptidesHumansUltrasonographyAmyloid beta-PeptidesAlzheimer diseaseBlood–brain barrierDrug delivery systemsHigh-intensity focusedUltrasonography

Identifiers

PMID42228053
PMCPMC13442609

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.