Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530732
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimers Disease A Pilot Study DIVA Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimers Disease A Pilot Study DIVA Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimers Disease Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group receiving dcLVA surgery plus standard medication or the control group receiving standard medication alone
Participants will
Undergo cognitive assessment and brain MRI assessment Undergo a lumbar puncture Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 05 mmolL 1ml gadodiamide 20ml 09 saline
Primary Outcome Measures The change in the sum of Clinical Dementia Rating Scale CDR scores at 12-month in relative to baseline
Participants will
Undergo cognitive assessment and brain MRI assessment Undergo a lumbar puncture Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 05 mmolL 1ml gadodiamide 20ml 09 saline
Primary Outcome Measures The change in the sum of Clinical Dementia Rating Scale CDR scores at 12-month in relative to baseline
Detailed Description:
This study aims to enroll patients diagnosed with AD Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group receiving dcLVA surgery plus standard medication or the control group receiving standard medication alone Following randomization patients will undergo cognitive and brain MRI assessments a lumbar puncture and an injection of 20ml of gadodiamide contrast agent at a concentration of 05 mmolL 1ml gadodiamide 20ml 09 saline MRI imaging scans will be conducted at 4 hours 24 hours and 48 hours post-injection to measure the dural signal unit ratio which will be used to assess glymphatic clearance function The study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods 7 days post-surgery 6 months and 12 months and will evaluate the safety of the two treatment approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None