ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-Guided Focused Ultrasound in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739905
• Other study ID #: AL003
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• 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 open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Description:

This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model 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 a single center in Canada and will enroll up to 30 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• 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
Canada	Division of Neurosurgery, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
InSightec	Focused Ultrasound Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and procedure related adverse events	Rate of adverse events following each treatment through end of study	6 months
Secondary	BBB Disruption and Closure	MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed	Immediately after the end of each ExAblate treatment and 24 hours after each treatment
Secondary	Change in Alzheimer's Disease Assessment Scale-Cognition	Mental cognition assessment	Baseline and 6 months
Secondary	Change in Amyloid Tracer uptake	PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment	Baseline and Day 8 following the third treatment