Neck surgery may help clear brain waste in Alzheimer's patients
NCT ID NCT07680660
First seen Jul 02, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This trial investigates whether a surgical procedure that connects lymph vessels in the neck to veins, combined with the standard drug donepezil, can slow cognitive decline in people with moderate Alzheimer's disease. The surgery aims to improve drainage of waste from the brain, which may reduce damage. Participants are randomly assigned to receive either the surgery plus donepezil or donepezil alone, and their cognitive function is tracked over 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil
- What this could lead to
- If successful, this could offer a new way to slow Alzheimer's progression by improving the brain's waste-clearing system.
- What could go wrong
- This is an early-stage surgical approach with unknown long-term benefits and risks. The surgery itself carries standard surgical risks, and it may not provide meaningful cognitive improvement.
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
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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
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. The patient or guardian signs the informed consent form; 2. Age 50-80 years (≥50 years, ≤80 years), male or female; 3. The first diagnosis is Alzheimer's disease with dementia; 4. MMSE score ≤24; 5. Positive β-amyloid protein PET imaging findings; 6. HAMD score ≤17; 7. Hachinski score ≤7; 8. No AD-related drug treatment has been received within the past 1 month; 9. ASA grade 1-3 (≥ grade 1, ≤ grade 3); 10. CDR-SB score of 9.5-15.5. Exclusion Criteria 1. Presence of contraindications to MRI, ICG angiography, or PET scan; 2. Presence of contraindications to lumbar puncture; 3. Severe heart disease or unstable hemodynamic status; 4. Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months; 5. Hepatic insufficiency, AST or ALT \>3 times the upper limit of normal; 6. Renal insufficiency, GFR \<60 mL/min or need for blood purification treatment; 7. MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.; 8. History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction; 9. Blood diseases, bleeding/coagulation disorders, coagulation dysfunction; 10. Abnormal thyroid function; 11. Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction; 12. Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; 13. The disease requires systemic use of steroids; 14. Drug addiction (including alcohol, narcotics, and alcohol dependence); 15. Severe infectious diseases, including HIV positivity, severe infection, etc.; 16. Severe psychiatric disease or potential suicide risk; 17. Within 3 years after radical surgery for malignant tumor; 18. Participation in other interventional clinical trials within the past three months; 19. In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up; 20. Other circumstances that the physician considers unsuitable for this clinical trial; 21. Anti-Aβ monoclonal antibody treatment has been received within half a year; 22. Previous neck surgery.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Huangpu, 200011, China
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