RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2018-09-28

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03671889

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.

Ages Eligible for Study:50 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

Delray Medical Center & Florida Atlantic University

Delray Beach, Florida, 33484

United States

Broward Health Medical Center & The University of Florida

Fort Lauderdale, Florida, 33316

United States

University of Florida Health Shands

Gainesville, Florida, 32608

United States

Baptist Health South Florida & Florida International University

Miami, Florida, 33176

United States

Advent Health

Orlando, Florida, 34747

United States

Tampa General Hospital

Tampa, Florida, 33612

United States

Weill Cornell Medicine

New York, New York, 10065

United States

The Ohio State University -Wexner Medical Center

Columbus, Ohio, 43210

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

West Virginia University Rockefeller Neuroscience Center

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: InSightec

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 Registration Dates

Study Start Date2018-09-28

Study Completion Date2025-12

Study Record Updates

Study Start Date2018-09-28

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Alzheimer Disease