Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)
NCT07073066 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376
Last updated 2026-05-12
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).
Conditions
- Alzheimers Disease
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.
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-13
- Primary Completion
- 2028-11-30
- Completion
- 2029-11-30
Countries
- China
Study Locations
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