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

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ClinicalTrials.gov Identifier: NCT03739905
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Focused Ultrasound Foundation
Information provided by (Responsible Party):
InSightec

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
Alzheimer Disease Device: Blood Brain Barrier (BBB) Disruption Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : December 6, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: ExAblate Neuro




Primary Outcome Measures :
  1. Device and procedure related adverse events [ Time Frame: 6 months ]
    Rate of adverse events following each treatment through end of study


Secondary Outcome Measures :
  1. BBB Disruption and Closure [ Time Frame: 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 [ Time Frame: Baseline and 6 months ]
    Mental cognition assessment

  3. Change in Amyloid Tracer uptake [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739905


Contacts
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Contact: Desiree Dorrough 469-607-0486 desireed@insightec.com
Contact: Roni Diaz 469-607-0521 Ronid@insightec.com

Locations
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Canada, Ontario
Division of Neurosurgery, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Allison Bethune    416-480-6100 ext 4831    allison.bethune@sunnybrook.ca   
Principal Investigator: Nir Lipsman, MD, PhD         
Sponsors and Collaborators
InSightec
Focused Ultrasound Foundation

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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03739905     History of Changes
Other Study ID Numbers: AL003
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders