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Neck surgery aims to drain Alzheimer's brain waste

NCT ID NCT07073066

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a surgical procedure called deep cervical lymphatic venous anastomosis (DC-LVA) in 376 people with moderate-to-severe Alzheimer's disease. The surgery connects lymph vessels in the neck to veins, aiming to improve drainage of waste from the brain. Researchers will compare cognitive decline over 12 months between those who get the surgery plus usual care and those who receive usual care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deep cervical lymphatic venous anastomosis (DC-LVA) surgery
What this could lead to
If it works, this surgery could slow cognitive decline in moderate-to-severe Alzheimer's disease by improving the brain's waste drainage.
What could go wrong
This is an early-stage surgical procedure with unknown long-term safety and efficacy. The trial is open-label, so both patients and doctors know who got the surgery, which can bias results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 376 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hopital, Capital Medical University

    RECRUITING

    Beijing, 100070, China

  • Dongguan Chashan Hospital

    RECRUITING

    Dongguan, Guangdong, China

  • First Affiliated Hospital of Shandong First Medical University

    ACTIVE_NOT_RECRUITING

    Jinan, Shandong, 250000, China

  • Guangdong Second People's Hospital

    RECRUITING

    Guangdong, Guangzhou, 510000, China

  • Jining First People's Hospital

    RECRUITING

    Jining, Shandong, 272000, China

  • Shandong Provincial Public Health Clinical Center

    RECRUITING

    Jinan, Shandong, 250000, China

  • Shandong Provincial Third Hospital

    RECRUITING

    Jinan, Shandong, 250000, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315000, China

  • Zhengzhou Central Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

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