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Single-center, Open, Prospective, Single-arm, Feasibility, Investigator-initiated Trail for Assessment of Initial Efficacy and Safety of High Intensity Focused Ultrasound 'ExAblate 4000 Type 2' for Blood Brain Barrier Disruption in Patients With Alzheimer's Disease
The proposed study is to evaluate initial efficacy and safety of the BBB disruption with transcranial MRI-guided focused ultrasound (ExAblate 4000 type 2.0) in patients with Alzheimer's disease. This study iw designed as a prospective, single-site, single-aarm, nonrandomized study. Assessments will be made before and three months after 2 sessions of BBB disruption with radiologic, nuclear medicine imaging and neurophysiological examinations. Relative safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
Department of Neurosurgery, Yonsei University College of Medici
Seoul, South Korea
Start Date
April 10, 2020
Primary Completion Date
December 1, 2020
Completion Date
December 1, 2020
Last Updated
August 25, 2020
6
ESTIMATED participants
transcranial magnetic resonance guided focused ultrasound BBB disruption
DEVICE
Lead Sponsor
Yonsei University
NCT04123314
NCT07178210
Data Source & Attribution
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