NCT04526262

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	transcranial magnetic resonance guided focused ultrasound BBB disruption	The ExAblate BBB disruption procedure will be performed with ExAblate 4000 type 2.0 system, and this will be performed twice every 3 months.

Timeline

• Start date: 2020-04-10
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-08-25
• Last updated: 2020-08-25

Locations

1 site across 1 country: South Korea