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Neck Lymph Surgery Plus Donepezil for Alzheimer's Disease Compared With Donepezil Alone

Compares neck lymph-vein surgery plus donepezil with donepezil alone in moderate Alzheimer's disease.

Key facts

Who runs it
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease
Status
Not yet recruiting
People taking part
216 people, planned
Started
15 Jul 2026
Expected to end
31 Mar 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil
  • Oral treatment with donepezil
Record updated
22 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 80 with a first diagnosis of Alzheimer's disease with dementia and a positive amyloid PET scan. It compares neck lymph vessel surgery plus donepezil with donepezil alone.

Age
50 to 80 years
Sex
Men and women can join
Disease stage
First diagnosis of Alzheimer's disease with dementia; MMSE score 24 or lower; CDR-SB score 9.5 to 15.5; HAMD score 17 or lower; Hachinski score 7 or lower; ASA grade 1 to 3
Earlier treatment
No Alzheimer's drug treatment in the past 1 month; no anti-Aβ monoclonal antibody treatment within half a year; no previous neck surgery
Biomarker or test result
Positive β-amyloid protein PET imaging

Main reasons for not taking part

  • Severe heart, lung, liver or kidney disease
  • Active or acute brain lesions on MRI, or a history of brain hemorrhage or infarction with severe lasting nerve problems
  • Blood or clotting disorders
  • Severe psychiatric disease or suicide risk, or drug or alcohol addiction
  • Severe infection, including HIV positivity

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

  • The patient or guardian signs the informed consent form
  • Age 50-80 years (≥50 years, ≤80 years), male or female
  • The first diagnosis is Alzheimer's disease with dementia
  • MMSE score ≤24
  • Positive β-amyloid protein PET imaging findings
  • HAMD score ≤17
  • Hachinski score ≤7
  • No AD-related drug treatment has been received within the past 1 month
  • ASA grade 1-3 (≥ grade 1, ≤ grade 3)
  • CDR-SB score of 9.5-15.5

Who cannot take part

  • Drug addiction (including alcohol, narcotics, and alcohol dependence)
  • Anti-Aβ monoclonal antibody treatment has been received within half a year
  • Previous neck surgery
  • Severe heart disease or unstable hemodynamic status
  • Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months
  • MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc
  • History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction
  • Blood diseases, bleeding/coagulation disorders, coagulation dysfunction
  • Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
  • The disease requires systemic use of steroids
  • Severe infectious diseases, including HIV positivity, severe infection, etc
  • Severe psychiatric disease or potential suicide risk
  • Within 3 years after radical surgery for malignant tumor
  • Hepatic insufficiency, AST or ALT >3 times the upper limit of normal
  • Renal insufficiency, GFR <60 mL/min or need for blood purification treatment
  • Presence of contraindications to MRI, ICG angiography, or PET scan
  • Presence of contraindications to lumbar puncture
  • Abnormal thyroid function
  • Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction
  • Participation in other interventional clinical trials within the past three months
  • In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up
  • Other circumstances that the physician considers unsuitable for this clinical trial

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 80 years old?

Where in China

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityShanghai, ChinaContact: Yixin Zhang, MD.No longer taking part

About the trial

What the trial wants to find out

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation. These included neuropsychological evaluations (MMSE, MoCA, CDR, BADL, IADL, NPI, AES), neuroimaging (MRI, PET, ultrasound), fluid biomarker analyses (CSF and blood levels of Aβ, Tau, neuroinflammatory factors, etc.), and safety monitoring. The primary efficacy endpoint was the change in CDR-SB score at 12 months post-treatment. Secondary endpoints included changes in multiple cognitive scales, neuroimaging metrics, and biomarkers at 18 months. Safety indicators encompassed adverse event recording, vital signs, and laboratory tests.

The 2 groups in the trial

  • Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil groupTreatment being tested

    Treatment: Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil and Oral treatment with donepezil

  • Oral donepezil groupExisting treatment, for comparison

    Treatment: Oral treatment with donepezil

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Cervical Lymph Vessel/Node-venous Anastomosis Combined With Donepezil Versus Donepezil Alone in the Treatment of Alzheimer's Disease
Plain-language title
Neck Lymph Surgery Plus Donepezil for Alzheimer's Disease Compared With Donepezil AloneGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07680660, who can take part
Record updated
22 July 2026