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

Sponsor
InSightec (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03739905
Collaborator
Focused Ultrasound Foundation (Other)
30
Enrollment
1
Location
1
Arm
47.8
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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 open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Condition or Disease Intervention/Treatment Phase
  • Device: Blood Brain Barrier (BBB) Disruption
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 6, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood Brain Barrier (BBB) Disruption

The ExAblate Model 4000 Type 2.0 System

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.
Other Names:
  • ExAblate Neuro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Device and procedure related adverse events [6 months]

      Rate of adverse events following each treatment through end of study

    Secondary Outcome Measures

    1. BBB Disruption and Closure [Immediately after the end of each ExAblate treatment and 24 hours after each treatment]

      MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed

    2. Change in Alzheimer's Disease Assessment Scale-Cognition [Baseline and 6 months]

      Mental cognition assessment

    3. Change in Amyloid Tracer uptake [Baseline and Day 8 following the third treatment]

      PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Neurosurgery, Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • InSightec
    • Focused Ultrasound Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InSightec
    ClinicalTrials.gov Identifier:
    NCT03739905
    Other Study ID Numbers:
    • AL003
    First Posted:
    Nov 14, 2018
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by InSightec
    Magnetic Resonance guided Focal Ultrasound (MRgFUS)
    Alzheimer's Disease
    ExAblate
    Blood Brain Barrier
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Oct 12, 2021