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NOT YET RECRUITING
NCT07073066
NA

Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).

Official title: Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2025-11-30

Completion Date

2029-11-30

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

PROCEDURE

DC-LVA treatment plus usual care

Through cervical incision, the deep cervical lymphatic tissue is anatomically dissected and anastomosed with the venous system of the neck. Under indocyanine green (ICG) navigation, the flow of lymphatic fluid into the vein could be observed via ICG tracing fluorescence after surgery.

OTHER

Usual care

The usual care group includes patients who were not using or were currently using medications for improving cognitive function.

Locations (1)

Beijing Tiantan Hopital, Capital Medical University

Beijing, China