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

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    InSightec
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Updated on 16 February 2024
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alzheimer's disease

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

Details
Condition Alzheimer's Disease
Age 50years - 85years
Treatment Blood Brain Barrier (BBB) Disruption
Clinical Study IdentifierNCT03671889
SponsorInSightec
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or Female between 50-85 years of age
Probable Alzheimer's Disease (AD)
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
Able to communicate sensations during the ExAblate MRgFUS procedure
Ambulatory

Exclusion Criteria

MRI Findings
Presence of unknown or MR unsafe devices anywhere in the body
Significant cardiac disease or unstable hemodynamic status
Relative contraindications to ultrasound contrast agent or PET amyloid tracer
History of a bleeding disorder
History of liver disease
Known cerebral or systemic vasculopathy
Significant depression and at potential risk of suicide
Any contraindications to MRI scanning
Any contraindication to lumbar puncture for collection of cerebral spinal fluid
Untreated, uncontrolled sleep apnea
History of seizure disorder or epilepsy
Severely Impaired renal function
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
Chronic pulmonary disorders
Positive human immunodeficiency virus (HIV)
Known apolipoprotein E allele (ApoE4) homozygosity
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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