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

NCT06530732 | Recruiting Phase 3

• 1 other identifier: KY2024106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• The rate of change in the total score of the Clinical Dementia Rating Scale

  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.

  Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month

Study Arms (2)

experimental group

EXPERIMENTAL

receiving dcLVA surgery plus standard medication

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

control group

ACTIVE COMPARATOR

receiving standard medication alone

Drug: Lecanemab

Interventions

Deep Cervical lymphatlc-Venous Anastomosis Surgery PROCEDURE

Cervical deep lymphatic-venous anastomosis (dcLVA) can promote the flow of cerebrospinal fluid within the glymphatic system. The procedure involves connecting deep cervical lymphatic vessels to veins, reducing pressure on lymph nodes and allowing lymphatic fluid from high-pressure vessels to flow into the lower-pressure venous system. This surgical intervention enhances the clearance of waste in the glymphatic system, particularly amyloid-beta (Aβ) and tau proteins. By facilitating the removal of these AD-associated proteins from the brain, dcLVA can reduce local tissue fibrosis and cervical nerve compression, potentially reversing degenerative changes, slowing disease progression, and improving the quality of life for AD patients.

experimental group

Lecanemab DRUG

The newly approved anti-beta-amyloid (Aβ) monoclonal antibody Lecanemab can delay AD progression but is only suitable for patients in the early stages. For those with moderate to severe AD, Lecanemab is not effective.

control group; experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)