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

Zhejiang Provincial People's Hospital

Status and phase: Enrolling; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Lecanemab; Procedure: Deep Cervical lymphatlc-Venous Anastomosis Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06530732

KY2024106

Details and patient eligibility

About

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

Full 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 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

experimental group

Experimental group

Description:

receiving dcLVA surgery plus standard medication

Treatment:

Procedure: Deep Cervical lymphatlc-Venous Anastomosis Surgery

Drug: Lecanemab

control group

Active Comparator group

Description:

receiving standard medication alone

Treatment:

Drug: Lecanemab