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Clinical trial Recruiting at 8 sites Interventional Ages 50 to 80

Deep cervical lymphatic‑venous anastomosis for treating Alzheimer's disease

Official title: Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)

Run by Beijing Tiantan Hospital · NCT07073066 · Data updated 2026-11-12

This test tries a surgical connection called deep cervical lymphatic‑venous anastomosis plus usual care to see if it slows cognitive decline over 12 months in people aged 50–80 with moderate‑to‑severe Alzheimer's disease.

More Alzheimer's Disease trials

Quick facts

Study typeInterventional
Ages50 Years to 80 Years
SexAll
Enrollment376 (estimated)
SponsorBeijing Tiantan Hospital
Academic / other
Locations9 sites (Dongguan, Guangdong and 8 other locations)
StatusRecruiting
StartedMarch 13, 2026
Main results expectedNovember 30, 2028
Study endsNovember 30, 2029
Registry record updatedMay 12, 2026
Trial IDNCT07073066 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people aged 50–80 with AD diagnosed by NIA‑AA criteria who have moderate‑to‑severe dementia (CDR‑GS ≥1, MMSE 10–20), have had symptoms >6 months, are stable on AD medications (or treatment‑naïve), and have an identified caregiver able to attend visits.

Probably not a fit

Patients are unlikely to benefit if they have other neurological conditions that affect cognition, major surgical contraindications, are outside the 50–80 age range, have very mild disease, or cannot provide informed consent and caregiver support.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, open‑label, blinded‑endpoint, randomized controlled trial enrolling 754 people with moderate‑to‑severe Alzheimer's disease across centers in China. Participants are randomly assigned to receive deep cervical lymphatic‑venous anastomosis (DC‑LVA) plus usual care or usual care alone, with clinical assessments and biomarker imaging at baseline and follow‑up. The primary outcome is change in the Clinical Dementia Rating Sum of Boxes (CDR‑SB) at 12 months, and secondary outcomes include amyloid PET measures and safety endpoints. The trial targets patients with CDR global score ≥1 and MMSE 10–20, and requires an identified caregiver to accompany follow‑up visits.

Why it matters

Potential benefit: If successful, the procedure could slow clinical decline and lower brain amyloid signals in people with moderate‑to‑severe Alzheimer's disease, offering a new therapeutic option where few exist.

How similar studies have gone: Small case series have suggested possible benefit from DC‑LVA, but there are no prior randomized controlled trials testing this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 50-80 years, male or female.
2. Diagnosed with AD according to NIA-AA criteria.
3. Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
4. Mini-Mental State Examination (MMSE) score 10-20.
5. The course of AD more than 6 months.
6. If receiving an approved AD treatment, must be on a stable drug dose for at least 3 months prior to Baseline. AD Treatment-naïve subjects can be entered into the study.
7. Have an identified caregiver (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The caregiver must accompany with the participant at all study follow-up visits.
8. Signed informed consent (from the participant or their relative, and the caregiver).

Exclusion Criteria:

1. Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial infections, metabolic encephalopathy, etc.
2. Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.
3. Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
4. Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.
5. 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.
6. History of drug or alcohol abuse or dependence.
7. History of malignant tumors or prior radiotherapy or surgery involving the head and neck.
8. Major surgical procedures or severe head or body trauma within the past 30 days.
9. Presence of other life-threatening conditions with an expected survival time of less than 2 years.
10. Contraindications to head MRI (including cardiac pacemakers/defibrillators, ferromagnetic metal implants, etc.).
11. Severe diseases or functional impairment of the heart, lungs, liver, kidneys, or other solid organs, making the patient unable to tolerate anesthesia or DC-LVA.
12. Severe bleeding tendency (including but not limited to): platelet count \<100×10⁹/L; heparin therapy within the last 48 hours with APTT ≥35 seconds; ongoing warfarin use with INR \>1.7.
13. Requirement for long-term use of antithrombotic medications, with inability to discontinue them before surgery or potential risks associated with discontinuation.
14. Uncontrolled persistent hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg).
15. Co-infection with HIV or Treponema pallidum, or any uncontrolled infectious disease.
16. Use of other investigational drugs or devices within 30 days prior to obtaining informed consent, or current participation in other interventional clinical studies.
17. Pregnancy, lactation, potential for pregnancy, or plans for pregnancy during the study period.
18. Immediate family members of the investigator (spouse, parents, children, or siblings), staff of the research institution or third-party organizations, or any other individuals with potential conflicts of interest related to the study.

Where it's running

  • Dongguan Chashan Hospital
    Dongguan, Guangdong, China     Recruiting
  • Guangdong Second People's Hospital
    Guangdong, Guangzhou, China     Recruiting
  • Zhengzhou Central Hospital
    Zhengzhou, Henan, China     Recruiting
  • Shandong Provincial Public Health Clinical Center
    Jinan, Shandong, China     Recruiting
  • Shandong Provincial Third Hospital
    Jinan, Shandong, China     Recruiting
  • Jining First People's Hospital
    Jining, Shandong, China     Recruiting
Show 3 more locations
  • The First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China     Recruiting
  • Beijing Tiantan Hopital, Capital Medical University
    Beijing, China     Recruiting
  • First Affiliated Hospital of Shandong First Medical University
    Jinan, Shandong, China     Active not recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.