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

Official 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.

Eligibility Requirements

• Minimum Age: 30 Years
• Maximum Age: 80 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 186 participants

Study Arms

• Surgical treatment (EXPERIMENTAL)
  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.

Interventions

• PROCEDURE: Deep cervical lymphatic-venous anastomosis — 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.
• DRUG: Donepezil drug treatment — 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.

Primary Outcomes

• ADAS-cog score (baseline,48 weeks)

Secondary Outcomes

• 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)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contact Information

• Yijun Cheng, Doc — CONTACT
  Phone: 15021058538
  Email: cyj12574@rjh.com.cn

Study Officials

• Yijun Cheng, Doc — PRINCIPAL_INVESTIGATOR
  Ruijin Hospital
• Hanbing Shang — PRINCIPAL_INVESTIGATOR
  Ruijin Hospital

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