Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474013
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
A Clinical Trial to Evaluate the Initial Safety and Efficacy of Repetitive BBB Blood Brain Barrier Disruption Using High Intensity Focused Ultrasound ExAblate 4000 Type 21 in Patients With Alzheimers Disease
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
Initial Safety and Efficacy of Repetitive BBB Blood Brain Barrier Disruption Using High Intensity Focused Ultrasound ExAblate 4000 Type 21 in Patients With Alzheimers Disease Single-center Open Prospective Single-arm Feasibility Investigator-initiated Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is designed to evaluate the initial safety and efficacy of opening the blood brain barrier BBB in patients with Alzheimers disease using the ExAblate 4000 Type 21 a MR guided high-intensity focused ultrasound surgical device that disrupts brain tissue
Detailed Description:
This clinical trial aims to evaluate the initial safety and efficacy of opening the blood brain barrier BBB in patients with Alzheimers disease using the ExAblate 4000 Type 21 a MR guided high-intensity focused ultrasound surgical device that disrupts brain tissue It is designed as a single-center open prospective single-arm feasibility investigator-initiated trial Patients with Alzheimers disease who require opening of the blood-brain barrier will be referred to this clinical trial Those who voluntarily sign a signed consent form after receiving a full explanation of the clinical trial undergo a screening test Those who fulfill all inclusionexclusion criteria will be enrolled in this clinical trial and assigned an enrollment number Only subjects enrolled in this clinical trial will undergo BBB opening blood brain barrier disruption using ExAblate 4000 Type 21 a high-intensity focused ultrasound surgical device to open the BBB by 40-60 cc After completion of the procedure the participants will receive follow-up observation for the procedure for at least 2 hours after the procedure At this time the investigator checks whether an adverse event that causes dropout and if the subject is dropped out follow-up observation of the adverse event continues
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None