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

NCT07058129 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-090-02
• Study Type: observational
• Target: 814
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, prospective registry is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in reduing the clinical dementia rating-sum of boxes (CDR-SB) score of Alzheimer's Disease (AD) patients at 12 months after surgery in the real-world.

Conditions

Alzheimers Disease

Keywords

Alzheimers disease; Cervical lymphatic venous anastomosis; Registry

Outcome Measures

Primary Outcomes (2)

• The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery

  The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)

  From baseline to 12th months after surgery

• The incidence of perioperative complications within 7 days after surgery

  The incidence of perioperative complications

  From baseline to 7th days after surgery

Secondary Outcomes (7)

• The Change of Clinical Dementia Rating-Sum of Boxes score

  From baseline to 3th, 6th, 18th, 24th months after surgery

• The Change of Neuropsychiatric Inventory Score

  From baseline to 3th, 6th, 12th,18th, 24th months after surgery

• The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score

  From baseline to 3th, 6th, 12th, 18th, 24th months after surgery

• The Change of Zarit Caregiver Interview of Alzheimer's Disease Score

  From baseline to 3th, 6th, 12th,18th, 24th months after surgery

• The Change of Mini-Mental State Examination Score

  From baseline to 3th, 6th, 12th, 18th, 24th months after surgery

Interventions

Deep cervical lymphatic venous anastomosis PROCEDURE

The intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). 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.

Also known as: lymphatic venous anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AD patients who received DC-LVA treatment

You may qualify if:

• Age ≥ 18 years, male or famale.
• Diagnosed with AD according to the NIA-AA criteria.
• Patients who have received DC-LVA treatment;
• Signed informed consent (by the subject or their relative, and caregiver)

You may not qualify if:

• Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may prevent the completion of cognitive function assessments.
• The subject lacks a stable and reliable caregiver to accompany with them during entire study follow-up visits.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hopital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yuesong Pan

CONTACT

0086-010-59975807; yuesongpan@aliyun.com

Yilong Wang

CONTACT

0086-010-67092222; yilong528@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: July 10, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)