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ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood Brain Barrier (BBB) Disruption

About this trial

This is an interventional device feasibility trial for Alzheimer Disease focused on measuring Alzheimer Disease, Alzheimer Syndrome, Magnetic Resonance guided Focal Ultrasound (MRgFUS), Blood-Brain Barrier, ExAblate

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Positive human immunodeficiency virus (HIV)
Known apolipoprotein E allele (ApoE4) homozygosity

Sites / Locations

Delray Medical Center & Florida Atlantic UniversityRecruiting
Broward Health Medical Center & The University of FloridaRecruiting
Baptist Health South Florida & Florida International UniversityRecruiting
Weill Cornell MedicineRecruiting
The Ohio State University -Wexner Medical Center
University of Texas Southwestern Medical CenterRecruiting
West Virginia University Rockefeller Neuroscience CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood Brain Barrier (BBB) Disruption

Arm Description

ExAblate Model 4000 Type 2.0 System

Outcomes

Primary Outcome Measures

Device and procedure related adverse events

Rate of adverse events following each treatment through end of study

Secondary Outcome Measures

Full Information

NCT ID

NCT03671889

First Posted

August 3, 2018

Last Updated

July 11, 2022

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT03671889

Brief Title

ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

Official Title

Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 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 up to 8 sites in the United States and will enroll up to 30 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer Disease, Alzheimer Syndrome, Magnetic Resonance guided Focal Ultrasound (MRgFUS), Blood-Brain Barrier, ExAblate

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Subjects who meet study eligibility will undergo treatment procedures in groups by staged volumes.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood Brain Barrier (BBB) Disruption

Arm Type

Experimental

Arm Description

ExAblate Model 4000 Type 2.0 System

Intervention Type

Device

Intervention Name(s)

Blood Brain Barrier (BBB) Disruption

Other Intervention Name(s)

ExAblate Neuro

Intervention Description

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

Primary Outcome Measure Information:

Title

Device and procedure related adverse events

Description

Rate of adverse events following each treatment through end of study

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

BBB Disruption and Closure

Description

MR images post-procedure to verify that the BBB was disrupted and subsequently closed within 24 hours.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Positive human immunodeficiency virus (HIV) Known apolipoprotein E allele (ApoE4) homozygosity

Facility Information:

Facility Name

Delray Medical Center & Florida Atlantic University

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny Zucker, MS

Phone

561-235-3767

JennyZucker712@gmail.com

First Name & Middle Initial & Last Name & Degree

Lloyd Zucker, MD, FAANS

Facility Name

Broward Health Medical Center & The University of Florida

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Celena Bodie

Phone

954-786-6736

cbodie@browardhealth.org

First Name & Middle Initial & Last Name & Degree

Shaye Moskowitz, MD PhD

Facility Name

Baptist Health South Florida & Florida International University

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margarita Mederos

Phone

786-596-1845

Margarita.mederos@BaptistHealth.net

First Name & Middle Initial & Last Name & Degree

Michael W. McDermott, MD

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachael Olovyannikov

Phone

212-746-7373

rao4005@med.cornell.edu

First Name & Middle Initial & Last Name & Degree

Michael Kaplitt, M.D., PhD

Facility Name

The Ohio State University -Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elaine Most, MS

Phone

636-634-0478

elaine.most@utsouthwestern.edu

First Name & Middle Initial & Last Name & Degree

Bhavya R Shah, MD

Facility Name

West Virginia University Rockefeller Neuroscience Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kiley Everson, RN, BSN

Phone

304-293-9146

kiley.everson@hsc.wvu.edu

First Name & Middle Initial & Last Name & Degree

Ali R Rezai, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34815790

Citation

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.

Results Reference

derived

PubMed Identifier

33399511

Citation

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.

Results Reference

derived

Learn more about this trial

ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

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