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

Phase 3

Recruiting

• Conditions: Alzheimer's Disease
• Interventions: Procedure: Deep Cervical lymphatlc-Venous Anastomosis Surgery; Drug: Lecanemab

• Registration Number: NCT06530732
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief 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 ...

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 cogniti...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study Start: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

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Exclusion Criteria

• Inability to cooperate with lumbar puncture;
• Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
• Significant organ dysfunction (heart, lung, liver, kidney);
• Coagulation disorders or contraindications to surgery;
• Inability to fully cooperate with follow-up visits.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Deep Cervical lymphatlc-Venous Anastomosis Surgery	receiving dcLVA surgery plus standard medication
experimental group	Lecanemab	receiving dcLVA surgery plus standard medication
control group	Lecanemab	receiving standard medication alone

Primary Outcome Measures

Name	Time	Method
The rate of change in the total score of the Clinical Dementia Rating Scale	Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month	The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline , using the Chinese version of the CDR scale, with a score range of 0-3 points for each item.The total score ranges from a minimum of 0 points to a maximum of 18 points, where a higher score indicates a worse outcome.

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China