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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03671889
• Other study ID #: AL002
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• Blood Brain Barrier (BBB) Disruption
Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.

Locations

Country	Name	City	State
United States	The Ohio State University -Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
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	West Virginia University Rockefeller Neuroscience Center	Morgantown	West Virginia
United States	Weill Cornell Medicine	New York	New York
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BBB Disruption and Closure	MR images post-procedure to verify that the BBB was disrupted and subsequently closed within 24 hours.	Immediately after the end of each ExAblate treatment and 24 hours post treatment
Primary	Device and procedure related adverse events	Rate of adverse events following each treatment through end of study	5 years