ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease

January 16, 2026 updated by: InSightec

A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-Guided Focused Ultrasound in Patients With Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain.This study will be conducted at a single center in Canada and will enroll up to 30 patients.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Division of Neurosurgery, Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Brain Barrier (BBB) Disruption
The ExAblate Model 4000 Type 2.0 System
Device: Blood Brain Barrier (BBB) Disruption
Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Other Names:
  • ExAblate Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and procedure related adverse events
Time Frame: 6 months
Rate of adverse events following each treatment through end of study
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BBB Disruption and Closure
Time Frame: Immediately after the end of each ExAblate treatment and 24 hours after each treatment
MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed
Immediately after the end of each ExAblate treatment and 24 hours after each treatment
Change in Alzheimer's Disease Assessment Scale-Cognition
Time Frame: Baseline and 6 months
Mental cognition assessment
Baseline and 6 months
Change in Amyloid Tracer uptake
Time Frame: Baseline and Day 8 following the third treatment
PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment
Baseline and Day 8 following the third treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Collaborators

Focused Ultrasound Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

April 9, 2025

Study Completion (Actual)

April 9, 2025

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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