Home Diseases and Conditions Alzheimer’s Disease 

Alzheimer's Disease 

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites. There are also clinical trials that may be of interest to patients.

Overview

Focused ultrasound is a rapidly evolving, noninvasive therapeutic technology that is improving the quality and longevity of life and decreasing the cost of care for millions of patients with a variety of serious medical disorders. It offers a disruptive, game changing alternative or complement to surgery, radiation therapy, drug delivery, and cancer immunotherapy. This novel technology precisely focuses beams of ultrasound energy on targets deep in the body without affecting surrounding normal tissue. Where the beams converge, the ultrasound can produce a variety of therapeutic effects without incisions or radiation.

For Alzheimer’s disease, focused ultrasound temporarily opens the blood-brain barrier (BBB), a naturally occurring barrier of tightly aligned cells along blood vessels that normally inhibits the diffusion of medications and immune cells into the brain.

Benefits

Currently, there is no cure or effective treatment for Alzheimer’s disease. Potentially promising drug and antibody therapies have proven ineffective due to their inability to cross the BBB and enter the brain

Advantages:

  • Noninvasive – no incisions, no risk of infection or bleeding, less pain, and rapid recovery
  • Image-guided – minimal damage to surrounding tissue
  • Safe, temporary, and repetitive opening of the BBB – enhancing the delivery of therapeutics and immune cells directly to the brain target site

Mechanisms of Action

Focused ultrasound delivers a variety of effects on tissue, and the following mechanisms are currently in use or under investigation for the treatment of Alzheimer’s disease.

Enhanced Therapeutic Delivery

  • Blood-Brain Barrier Opening: increased diffusion of therapeutics and immune cells to targeted brain tissue
  • Local release of carrier-mediated payload: locally activating encapsulated therapies

Immune Modulation

  • Enhanced immunotherapeutic delivery and activation: increases tumor exposure to immunotherapies
  • Increased immune cell infiltration: promoting migration of immune cells into target tissue

Neuromodulation

  • Excitatory/Inhibitory modulation of neuronal activity and nerve fibers: altering neuronal firing and circuitry

Other

  • Stem cell homing: guiding stem cells to targeted tissue, supporting repair and regeneration
  • Glymphatic stimulation: enhancing the function of the brain’s waste-clearing system

Regulatory Authorizations

Europe, CE Marking (Includes all countries in the EU, plus Norway, Iceland, and Liechtenstein): NEUROLITH by Storz Medical

Clinical Trials

The following is a curated list of clinical trials exploring the use of focused ultrasound to address Alzheimer’s disease.

The following clinical trials have completed enrolling patients, and results are expected soon.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.

Preclinical Laboratory Studies

The following studies are partially or fully funded by the Focused Ultrasound Foundation.

  • Development of a transcranial focused ultrasound system for the Alzheimer’s disease (AD) transgenic pig to open blood brain barrier for stem cell therapy (Jeju National University)
  • Enhancing Neurogenesis by Focused Ultrasound-mediated Plasmid Delivery (University of Virginia)
  • Focused Ultrasound-Enhanced Systemic Delivery of Lipid Nanoparticles for BrainWide Gene Therapy in Alzheimer’s Disease (Columbia University)
  • Focused Ultrasound-Mediated Microglial Activation to Promote Amyloid Beta Clearance in Alzheimer’s Disease (University College London)
  • In Vivo PET imaging of ultrasound-assisted therapies in Alzheimer’s Disease (Stanford University)
  • Promoting oligodendrogenesis with ultrasound for Alzheimer’s disease: A noninvasive, non-pharmacological regenerative strategy (Sunnybrook Health Sciences Centre)
  • Sonogenetics-enabled spatial and temporal expression of transcription factors for direct programming of human stem cells (Penn State University)

Manufacturers

The following manufacturers are active in the field of focused ultrasound and its applications for Alzheimer’s disease.

  • Acoustiic, Inc. | Bellevue, WA, United States | www.acoustiic.com
  • BrainSonix Corp. | Sherman Oaks, CA, United States | www.brainsonix.com
  • Carthera | Paris, France | www.carthera.eu
  • Ceretas Pty., Ltd. | Brisbane, Australia | www.ceretas.com.au
  • Curapulse Co., Ltd | Busan, South Korea | www.cura-pulse.com
  • Deepson Bio, Ltd. | Chuncheon-si, South Korea | www.deepsonbio.com
  • Delsona Therapeutics, Inc. | New York, NY, United States | www.delsona.com
  • Grey Matter Neurosciences | Toronto, ON, Canada | www.greymatterneurosciences.com
  • MBInsight Systems | Miaoli County, Taiwan
  • Microvascular Therapeutics, LLC | Tucson, AZ, United States | www.mvtpharma.com
  • Neumous, Inc. | Cheongju-si, South Korea | www.neumous.com
  • Neurosona Co., Ltd. | Seoul, South Korea | www.neurosona.com
  • Sanmai Technologies, PBC | Los Altos, CA, United States | www.sanmai.tech
  • Sound Wave Innovation Co., Ltd. | Tokyo, Japan | www.sw-innovation.com
  • Storz Medical, AG | Tägerwilen, Switzerland | www.storzmedical.com
  • Zhongke Green Valley Medical Technology Co., Ltd. | Shenzhen, China | en.gvbraintech.com

Media & Videos

A Mother’s Mind Appears Restored: Might Ultrasound Be a Cure For Alzheimer’s?
South China Morning Post – January 23, 2026

An Ultrasound Experiment Tackles a Giant Problem in Brain Medicine
New York Times – January 10, 2024

Breakthrough in Treating Alzheimer’s Using Targeted Drug Delivery Reported in New England Journal of Medicine
West Virginia University Medicine – January 3, 2024

Revolutionary New Ultrasound Procedure Could Delay Ageing and Memory Loss
BBC Science Focus – September 11, 2023

New Ultrasound Therapy Could Help Treat Alzheimer’s, Cancer
The Wall Street Journal – July 31, 2023

Key Publications

Suggested Reading: Focused Ultrasound: Transforming treatment of Neurodegenerative Diseases. August 2022

Suggested Reading: Focused Ultrasound for Alzheimer’s Disease. January 2022. 

Wang M, Zhang B, Guo R, Wang H, Wu D, Peng X, Guo H, Duan J, Yang W, Ren P, Zhang S. Restoration of autophagy-lysosomal function via transcranial focused ultrasound stimulation ameliorates β-amyloid pathology and cognitive deficits in an Alzheimer’s disease model. Ultrasonics. 2026 Mar 24;165:108075. doi: 10.1016/j.ultras.2026.108075. PMID: 41886893

Li F, Wu L, Feng X, Li Y, Fan H. Extracellular Vesicles in Alzheimer’s Disease: Dual Roles in Pathogenesis, Promising Avenues for Diagnosis and Therapy. Pharmaceutics. 2026 Jan 5;18(1):70. doi: 10.3390/pharmaceutics18010070. PMID: 41599177 

 Li X, Yan S, Li M, Liu R, Lu Q, Lu M, Bai F, Shen QD. Piezoelectric nanoparticle-driven rhythmic ultrasound neuromodulation for treatment of early-stage Alzheimer’s disease. Biomaterials. 2026 May;328:123905. doi: 10.1016/j.biomaterials.2025.123905. Epub 2025 Dec 11. PMID: 41389410 

 Lee S, Kum J, Kim K, Park TY, Ko H, Na DL, Kang SY, Kim H, Kim Y, Kim J. Clearance of amyloid plaque via focused ultrasonication in a mouse model of Alzheimer’s disease. Theranostics. 2026 Jan 1;16(5):2310-2323. doi: 10.7150/thno.122123. eCollection 2026. PMID: 41424842 

Liu J, He J, Chen X, Wu D. Manipulation of glymphatic system by focused ultrasound: A promising treatment of neurological diseases. J Cereb Blood Flow Metab. 2025 Oct 22:271678X251383857. doi: 10.1177/0271678X251383857. PMID: 41123223 

Xiao H, Sreejith A, Howson I, Cruz AA, Key T, Iliff JJ, Aryal M. Focused Ultrasound Enhances Glymphatic Transport Robustly Across Anesthesia Levels. Ultrasound Med Biol. 2025 Oct;51(10):1701-1709. doi: 10.1016/j.ultrasmedbio.2025.06.009. Epub 2025 Jul 12. PMID: 40653395 

Liu J, He J, Chen X, Wu D. Manipulation of glymphatic system by focused ultrasound: A promising treatment of neurological diseases. J Cereb Blood Flow Metab. 2025 Oct 22:271678X251383857. doi: 10.1177/0271678X251383857. PMID: 41123223 

Xiao H, Sreejith A, Howson I, Cruz AA, Key T, Iliff JJ, Aryal M. Focused Ultrasound Enhances Glymphatic Transport Robustly Across Anesthesia Levels. Ultrasound Med Biol. 2025 Oct;51(10):1701-1709. doi: 10.1016/j.ultrasmedbio.2025.06.009. Epub 2025 Jul 12. PMID: 40653395 

Xie F, Ye Y, Hao J, Liu H, Richard SA, He S. Surgical advances in the treatment of Alzheimer’s disease: A comprehensive review. J Alzheimers Dis. 2025 Aug 13:13872877251364397. doi: 10.1177/13872877251364397. PMID: 40801842 

Xu H, Wang G, Jiang Z, Han Y, Zhao W, Zhang H, Liu H, Liu H, Li Z, Ji F. Ultrasmall Nanoparticles Mitigate Tau Hyperphosphorylation to Restore Synaptic Integrity and Boost Cognitive Function in Alzheimer’s Disease. Adv Healthc Mater. 2025 Aug;14(20):e2500941. doi: 10.1002/adhm.202500941. Epub 2025 May 16. PMID: 40376857 

de Koning LA, Vazquez-Matias DA, Beaino W, Vugts DJ, van Dongen GAMS, van der Flier WM, Ries M, van Vuurden DG, Vijverberg EGB, van de Giessen E. Drug delivery strategies to cross the blood-brain barrier in Alzheimer’s disease: a comprehensive review on three promising strategies. J Prev Alzheimers Dis. 2025 Aug;12(7):100204. doi: 10.1016/j.tjpad.2025.100204. Epub 2025 May 19. PMID: 40393907 

Zheng K, Tsitsos FN, Batts AJ, Ji R, Nuriel T, Konofagou EE, Leong KW. Focused ultrasound-mediated APOE4 knockdown in mouse brain. Alzheimers Dement. 2025 Jul;21(7):e70464. doi: 10.1002/alz.70464. PMID: 40665471 

Li W, Zha X, Zhang X, Dai H, Pu S, Yao X, Hui W, Xu R, Bao J, Yu J, Wei Y, Huang J, Guo N, Xu M, Zhao J, Cheng B, Luo Z. Enhanced Positron Emission Tomography Imaging of β-Amyloid through Focused Ultrasound-Mediated Gallium-68 Radiotracer Delivery across the Blood-Brain Barrier. ACS Chem Neurosci. 2025 Jul 28. doi: 10.1021/acschemneuro.5c00476. PMID: 40720733 

Click here for additional references from PubMed.