NCT03671889

Brief Summary

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 disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
44mo left

Started Sep 2018

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2018Jan 2030

First Submitted

Initial submission to the registry

August 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

9.3 years

First QC Date

August 3, 2018

Last Update Submit

January 8, 2026

Conditions

Alzheimer Disease

Keywords

Alzheimer DiseaseAlzheimer SyndromeMagnetic Resonance guided Focal Ultrasound (MRgFUS)Blood-Brain BarrierExAblate

Outcome Measures

Primary Outcomes (1)

  • Device and procedure related adverse events

    Rate of adverse events following each treatment through end of study

    5 years

Other Outcomes (1)

  • BBB Disruption and Closure

    Immediately after the end of each ExAblate treatment and 24 hours post treatment

Study Arms (1)

Blood Brain Barrier (BBB) Disruption

EXPERIMENTAL

ExAblate Model 4000 Type 2.0 System

Device: Blood Brain Barrier (BBB) Disruption

Interventions

Blood Brain Barrier (BBB) DisruptionDEVICE

Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.

Also known as: ExAblate Neuro
Blood Brain Barrier (BBB) Disruption

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female between 50-85 years of age
  • Probable Alzheimer's Disease (AD)
  • 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
  • Able to communicate sensations during the ExAblate MRgFUS procedure
  • Ambulatory

You may not qualify if:

  • MRI Findings
  • Presence of unknown or MR unsafe devices anywhere in the body
  • Significant cardiac disease or unstable hemodynamic status
  • Relative contraindications to ultrasound contrast agent or PET amyloid tracer
  • History of a bleeding disorder
  • History of liver disease
  • Known cerebral or systemic vasculopathy
  • Significant depression and at potential risk of suicide
  • Any contraindications to MRI scanning
  • Any contraindication to lumbar puncture for collection of cerebral spinal fluid
  • Untreated, uncontrolled sleep apnea
  • History of seizure disorder or epilepsy
  • Severely Impaired renal function
  • 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
  • Chronic pulmonary disorders
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Delray Medical Center & Florida Atlantic University

Delray Beach, Florida, 33484, United States

RECRUITING

Broward Health Medical Center & The University of Florida

Fort Lauderdale, Florida, 33316, United States

RECRUITING

University of Florida Health Shands

Gainesville, Florida, 32608, United States

RECRUITING

Baptist Health South Florida & Florida International University

Miami, Florida, 33176, United States

RECRUITING

Advent Health

Orlando, Florida, 34747, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33612, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

The Ohio State University -Wexner Medical Center

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

ACTIVE NOT RECRUITING

West Virginia University Rockefeller Neuroscience Center

Morgantown, West Virginia, 26506, United States

ACTIVE NOT RECRUITING

Related Publications (4)

  • Mehta RI, Carpenter JS, Mehta RI, Haut MW, Wang P, Ranjan M, Najib U, D'Haese PF, Rezai AR. Ultrasound-mediated blood-brain barrier opening uncovers an intracerebral perivenous fluid network in persons with Alzheimer's disease. Fluids Barriers CNS. 2023 Jun 16;20(1):46. doi: 10.1186/s12987-023-00447-y.

    PMID: 37328855DERIVED

  • Rezai AR, Ranjan M, Haut MW, Carpenter J, D'Haese PF, Mehta RI, Najib U, Wang P, Claassen DO, Chazen JL, Krishna V, Deib G, Zibly Z, Hodder SL, Wilhelmsen KC, Finomore V, Konrad PE, Kaplitt M; Alzheimer's Disease Neuroimaging Initiative. Focused ultrasound-mediated blood-brain barrier opening in Alzheimer's disease: long-term safety, imaging, and cognitive outcomes. J Neurosurg. 2022 Nov 4;139(1):275-283. doi: 10.3171/2022.9.JNS221565. Print 2023 Jul 1.

    PMID: 36334289DERIVED

  • Mathew AS, Gorick CM, Price RJ. Multiple regression analysis of a comprehensive transcriptomic data assembly elucidates mechanically- and biochemically-driven responses to focused ultrasound blood-brain barrier disruption. Theranostics. 2021 Oct 11;11(20):9847-9858. doi: 10.7150/thno.65064. eCollection 2021.

    PMID: 34815790DERIVED

  • Mehta RI, Carpenter JS, Mehta RI, Haut MW, Ranjan M, Najib U, Lockman P, Wang P, D'haese PF, Rezai AR. Blood-Brain Barrier Opening with MRI-guided Focused Ultrasound Elicits Meningeal Venous Permeability in Humans with Early Alzheimer Disease. Radiology. 2021 Mar;298(3):654-662. doi: 10.1148/radiol.2021200643. Epub 2021 Jan 5.

    PMID: 33399511DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SEQUENTIAL
Model Details: Subjects who meet study eligibility will undergo treatment procedures
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2018

First Posted

September 14, 2018

Study Start

September 28, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(10)