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Sound waves to the brain: a new hope for Alzheimer's?

NCT ID NCT03671889

Disease control Sponsor: InSightec Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device that uses focused ultrasound to temporarily open the blood-brain barrier in people with Alzheimer's disease. The goal is to see if this is safe and could help treatments reach the brain better. Fifty participants aged 50 to 85 with probable Alzheimer's will be treated and monitored for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
focused ultrasound (ExAblate Neuro device)
What this could lead to
If it works, this could help deliver Alzheimer's treatments more effectively to the brain, potentially slowing memory loss and cognitive decline.
What could go wrong
This is an early-stage safety study with only 50 participants, so it may not show clear benefit. The procedure carries risks like bleeding or swelling in the brain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or Female between 50-85 years of age 2. Probable Alzheimer's Disease (AD) 3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months 4. Able to communicate sensations during the ExAblate MRgFUS procedure 5. Ambulatory Exclusion Criteria: 1. MRI Findings 2. Presence of unknown or MR unsafe devices anywhere in the body 3. Significant cardiac disease or unstable hemodynamic status 4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer 5. History of a bleeding disorder 6. History of liver disease 7. Known cerebral or systemic vasculopathy 8. Significant depression and at potential risk of suicide 9. Any contraindications to MRI scanning 10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid 11. Untreated, uncontrolled sleep apnea 12. History of seizure disorder or epilepsy 13. Severely Impaired renal function 14. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research 15. Chronic pulmonary disorders 16. Positive human immunodeficiency virus (HIV) 17. Known apolipoprotein E allele (ApoE4) homozygosity

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 34747, United States

  • Baptist Health South Florida & Florida International University

    RECRUITING

    Miami, Florida, 33176, United States

  • Broward Health Medical Center & The University of Florida

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

    Contact Email: •••••@•••••

  • Delray Medical Center & Florida Atlantic University

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • The Ohio State University -Wexner Medical Center

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Florida Health Shands

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Texas Southwestern Medical Center

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75390, United States

  • Weill Cornell Medicine

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • West Virginia University Rockefeller Neuroscience Center

    ACTIVE_NOT_RECRUITING

    Morgantown, West Virginia, 26506, United States

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