RecruitingNot ApplicableNCT03671889

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

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

Sponsor

InSightec

Enrollment

50 participants

Start Date

Sep 28, 2018

Study Type

INTERVENTIONAL

Conditions

Alzheimer 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).

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria17

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

Interventions

DEVICEBlood 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.