A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease

NCT07060391 | Not Yet Recruiting Phase 3

• 1 other identifier: DCLVA
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied by moderate to severe cognitive dysfunction in these three hospitals from January 2025 to January 2027 were included. This research is expected to recruit a total of 186 patients with moderate to severe Alzheimer's disease.93patients received conventional medical treatment, Deep cervical lymphatic-venous anastomosis was performed in 93 patients.Comprehensively evaluate the efficacy and safety of the patients within 48 weeks after treatment.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• ADAS-cog score

  The improvement of 4 points by ADAS-cog is used as the judgment criterion for the clinical therapeutic effect, Compare the remission rates between the experimental group (surgery) and the control group (medication).

  baseline,48 weeks

Secondary Outcomes (5)

• Imaging data

  From the first week to the 48th week

• Cerebrospinal fluid examination

  From the first week to the 48th week

• Markers of Alzheimer's disease in the blood

  From the first week to the 48th week

• Surgery-related adverse reactions

  From the first week to the 48th week

• Quality-Adjusted Life Year

  From the first week to the 48th week

Study Arms (2)

Surgical treatment

EXPERIMENTAL

Deep cervical lymphatic-venous anastomosis

Procedure: Deep cervical lymphatic-venous anastomosis

Internal medicine conservative treatment

PLACEBO COMPARATOR

Donepezil drug ,5-10mg,qd,po. All patients stopped taking cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, Memegan, etc. after enrollment.

Drug: Donepezil drug treatment

Interventions

Deep cervical lymphatic-venous anastomosis PROCEDURE

Lymph node reconstruction was carried out using microsurgical techniques,improve cerebral lymphatic circulation and return, accelerate the excretion of pathological proteins, the metabolic products of the brain, from the brain. This is to delay the degenerative changes of the brain and the progression of Alzheimer's disease.

Surgical treatment

Donepezil drug treatment DRUG

All patients stopped taking cognitive-enhancing drugs after enrollment, and marketed therapeutic drugs include ginkgo biloba, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, memegan, etc.

Internal medicine conservative treatment

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient was clinically diagnosed with Alzheimer's disease and had a moderate to severe cognitive function score.
• Age: 30-80 years old.
• Gender is not limited.
• The patient or their family members authorize their willingness to participate in this clinical trial and sign the informed consent form.
• no contraindications for surgery.

You may not qualify if:

• A history of radiotherapy or surgery for the head and neck.
• Patients or their families with poor compliance who cannot strictly follow the rules.
• Patients who cannot tolerate surgery.
• Patients with other diseases that affect cognitive function.
• Patients who cannot tolerate donepezil drug treatment.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

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

Study Officials

• Yijun Cheng, Doc

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Hanbing Shang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yijun Cheng, Doc

CONTACT

15021058538; cyj12574@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 11, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share