Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's 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 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosed as an AD patient according to biological markers and clinical symptoms;

• Over 35 years old and with an MMSE or MOCA score ≤ 26;

• The patient or family member has signed an informed consent form.

Locations
Other Locations
China
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Experimental: experimental group
receiving dcLVA surgery plus standard medication
Active_comparator: control group
receiving standard medication alone
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov

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