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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Device: Blood Brain Barrier (BBB) Disruption

• Registration Number: NCT03671889
• Lead Sponsor: InSightec

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.

Study Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-09-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Blood Brain Barrier (BBB) Disruption	Blood Brain Barrier (BBB) Disruption	ExAblate Model 4000 Type 2.0 System

Primary Outcome Measures

Name	Time	Method
Device and procedure related adverse events	5 years	Rate of adverse events following each treatment through end of study

Trial Locations

Locations (10)

Advent Health; 🇺🇸 Orlando, Florida, United States

Delray Medical Center & Florida Atlantic University; 🇺🇸 Delray Beach, Florida, United States

Broward Health Medical Center & The University of Florida; 🇺🇸 Fort Lauderdale, Florida, United States

University of Florida Health Shands; 🇺🇸 Gainesville, Florida, United States

Baptist Health South Florida & Florida International University; 🇺🇸 Miami, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

The Ohio State University -Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

West Virginia University Rockefeller Neuroscience Center; 🇺🇸 Morgantown, West Virginia, United States