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Surgery to improve brain fluid drainage in severe Alzheimer's disease

Tests a neck lymph-to-vein surgery in people with severe Alzheimer's disease.

Key facts

Who runs it
Southwest Hospital, China
Where
Chongqing, ChinaSee the site
Trial code
Registry title
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
Status
Not yet recruiting
People taking part
59 people, planned
Started
1 Oct 2026
Expected to end
30 Sept 2029
Type of study
Interventional
Treatments tested
  • Deep Cervical Lymphovenous Anastomosis
  • Routine Treatment
Record updated
25 June 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 severe Alzheimer's disease who have not improved on standard drug treatment. All receive a neck lymph-vein bypass operation plus routine medication.

Age
50 to 80 years
Sex
Men and women
Disease stage
Severe Alzheimer's disease dementia, with a Mini-Mental State Examination (MMSE) score below 10. Memory and thinking have been getting worse for more than 6 months.
Earlier treatment
No improvement after more than 6 months of standard drug treatment.
Biomarker or test result
Alzheimer's disease confirmed by the 2018 NIA-AA research framework biomarker criteria.

Main reasons for not taking part

  • Other serious brain diseases that affect thinking or taking part in the study
  • Serious or unstable illness of the heart, liver, kidney, lungs or other organs, or life expectancy under 24 months
  • Conditions that make surgery unsafe, such as severe bleeding disorders
  • Bleeding in the skull or a head injury within the last year
  • Allergy to certain contrast agents or tracers used in scans, or any reason a PET scan cannot be done

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD
  • Aged 50 to 80 years (inclusive) at the time of signing informed consent
  • Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score < 10 points
  • Progressive cognitive deterioration for more than 6 months reported by patient or caregiver
  • No clinical improvement after more than 6 months of standardized drug treatment
  • Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits
  • Able to complete scale assessments and examinations independently or with companion assistance
  • Voluntarily comply with study procedures, examinations and surgical treatment
  • Patient or legal representative can sign written informed consent and abide by trial requirements
  • Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study

Who cannot take part

  • Alcohol or drug abuse/dependence within recent 1 year
  • Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance
  • Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months
  • Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment
  • History of intracranial hemorrhage or craniocerebral trauma within recent 1 year
  • Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir
  • Other conditions judged by investigators unsuitable for enrollment
  • Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR < 30ml/min)
  • Contraindications for PET examination

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

  • The First Affiliated Hospital of Army Medical University (Southwest Hospital)Chongqing, ChinaContact: Jingyu Chen, MDNo longer taking part

About the trial

What the trial wants to find out

Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function. This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE < 10). All patients receive bilateral DCLVA plus routine medication. The primary endpoint is change of CDR-SB score at 12 months post-operation. Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value. This study aims to verify the efficacy and safety of DCLVA for severe AD.

The group in the trial

  • Deep Cervical Lymphovenous Anastomosis plus Routine TreatmentTreatment being tested

    All participants receive one-time bilateral deep cervical lymphovenous anastomosis under microsurgery with indocyanine green lymphatic tracing. Conventional anti-Alzheimer's drugs are maintained throughout the study. All outcomes are compared with pre-operation baseline.

    Treatment: Deep Cervical Lymphovenous Anastomosis and Routine Treatment

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 Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease
Plain-language title
Surgery to improve brain fluid drainage in severe Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07669272, who can take part
Record updated
25 June 2026