Trial reportAlzheimer's research & therapy2022
Pilot study of repeated blood-brain barrier disruption in patients with mild Alzheimer's disease with an implantable ultrasound device.
Trial report in Alzheimer's research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03119961 (Phase 1/2 Open Single-arm Monocentric Study Evaluating the Tolerance and Interest of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SONOCLOUD® Implantable Medical Device in Mild Alzheimer's Disease Patients), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Phase 1/2 Open Single-arm Monocentric Study Evaluating the Tolerance and Interest of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SONOCLOUD® Implantable Medical Device in Mild Alzheimer's Disease Patients (MMSE 20-26)
Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- Ultrasound-induced blood-brain barrier opening in Alzheimer's disease: a systematic review of clinical studies.Aging clinical and experimental research · 2026Pooled it
- Focused ultrasound therapy for Alzheimer's disease: exploring the potential for targeted amyloid disaggregation.Frontiers in neurology · 2024Pooled it
- Safety, Efficacy and Clinical Applications of Focused Ultrasound-Mediated Blood Brain Barrier Opening in Alzheimer's Disease: A Systematic Review.The journal of prevention of Alzheimer's disease · 2024Pooled it
- Repeated blood-brain barrier opening with a nine-emitter implantable ultrasound device in combination with carboplatin in recurrent glioblastoma: a phase I/II clinical trial.Nature communications · 2024Trial
- Focused Ultrasound is Poised to Take Non-Viral Gene Therapies to the Blood-Brain Barrier - and Beyond.Cell biomaterials · 2026Article
- Development of skull-implanted ultrasound for blood-brain barrier opening and drug delivery in neuro-oncology.Neuro-oncology advances · 2026Review
- Low-intensity transcranial ultrasound neuromodulation promotes neuronal regeneration: A new hope for noninvasive treatment of neurodegenerative diseases.Neural regeneration research · 2026Article
- Transport pathways across the blood-brain barrier for waste clearance and drug delivery.Fluids and barriers of the CNS · 2026Review
- Pharmacological rescue of mitochondrial dysfunction, neurite degeneration, and premature death of ALS and AD iPSC-derived neurons.bioRxiv : the preprint server for biology · 2026Article
- Development and Implementation of a Radiation Safety Screening Protocol for a Clinical Study Using Amyloid Positron Emission Tomography Imaging.Ochsner journal · 2026Article
- Alteration of Essential Cell Function by Ultrasound-Targeted Microbubble Cavitation.Current cardiology reports · 2025Review
- Drug delivery strategies to cross the blood-brain barrier in Alzheimer's disease: a comprehensive review on three promising strategies.The journal of prevention of Alzheimer's disease · 2025Review
- Crossing the blood-brain barrier: emerging therapeutic strategies for neurological disease.The Lancet. Neurology · 2025Review
- A pre-clinical MRI-guided all-in-one focused ultrasound system for murine brain studies.Scientific reports · 2025Article
- Identifying new therapeutics for focused ultrasound-enhanced drug delivery in the management of glioblastoma.Frontiers in oncology · 2025Review
- A comprehensive review of advanced focused ultrasound (FUS) microbubbles-mediated treatment of Alzheimer's disease.Heliyon · 2024Review
- Consensus review on strategies to improve delivery across the blood-brain barrier including focused ultrasound.Neuro-oncology · 2024Review
- Latest Perspectives on Alzheimer's Disease Treatment: The Role of Blood-Brain Barrier and Antioxidant-Based Drug Delivery Systems.Molecules (Basel, Switzerland) · 2024Review
- Blood-brain barrier disruption: a culprit of cognitive decline?Fluids and barriers of the CNS · 2024Review
- Scanning ultrasound-mediated memory and functional improvements do not require amyloid-β reduction.Molecular psychiatry · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundTemporary disruption of the blood-brain barrier (BBB) using pulsed ultrasound leads to the clearance of both amyloid and tau from the brain, increased neurogenesis, and mitigation of cognitive decline in pre-clinical models of Alzheimer's disease (AD) while also increasing BBB penetration of therapeutic antibodies. The goal of this pilot clinical trial was to investigate the safety and efficacy of this approach in patients with mild AD using an implantable ultrasound device.
methodsAn implantable, 1-MHz ultrasound device (SonoCloud-1) was implanted under local anesthesia in the skull (extradural) of 10 mild AD patients to target the left supra-marginal gyrus. Over 3.5 months, seven ultrasound sessions in combination with intravenous infusion of microbubbles were performed twice per month to temporarily disrupt the BBB.
resultsA total of 63 BBB opening procedures were performed in nine subjects. The procedure was well-tolerated. A non-significant decrease in amyloid accumulation at 4 months of - 6.6% (SD = 7.2%) on
conclusionsThese results demonstrate the safety of ultrasound-based BBB disruption and the potential of this technology to be used as a therapy for AD patients. Research of this technique in a larger clinical trial with a device designed to sonicate larger volumes of tissue and in combination with disease-modifying drugs may further enhance the effects observed.
trial registrationClinicalTrials.gov, NCT03119961.
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Registered trials
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.