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



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:3/30/2019
Start Date:September 28, 2018
End Date:December 2024
Contact:Desiree Dorrough
Email:desireed@insightec.com
Phone:469-607-0486

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Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable 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 disrupt the blood-brain barrier (BBB) in patients with probable
Alzheimer's Disease (AD).

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 4 sites in the United States and will enroll up to 10 patients.

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
We found this trial at
3
sites
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Vibhor Krishna, MD
Phone: 614-293-2587
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Morgantown, West Virginia 26506
Principal Investigator: Ali R Rezai, MD
Phone: 304-293-9638
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New York, New York 10065
Principal Investigator: Michael Kaplitt, M.D., PhD
Phone: 212-746-1788
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New York, NY
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