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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Division of Neurosurgery, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Device and procedure related adverse events
Rate of adverse events following each treatment through end of study
Time frame: 6 months
BBB Disruption and Closure
MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed
Time frame: Immediately after the end of each ExAblate treatment and 24 hours after each treatment
Change in Alzheimer's Disease Assessment Scale-Cognition
Mental cognition assessment
Time frame: Baseline and 6 months
Change in Amyloid Tracer uptake
PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment
Time frame: Baseline and Day 8 following the third treatment
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