Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)

Launched by BEIJING TIANTAN HOSPITAL · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical procedure called deep cervical lymphatic venous anastomosis (DC-LVA) to see if it can help people with moderate to severe Alzheimer’s disease. Researchers want to find out if adding this surgery to the usual treatments can slow down memory and thinking problems better than usual care alone over a year. The surgery aims to improve how the brain clears waste, which might affect Alzheimer’s symptoms.

People who may join the study are adults between 50 and 80 years old who have been diagnosed with moderate to severe Alzheimer’s disease. They should have a caregiver who can support them and attend all study visits. Participants may already be on Alzheimer’s medicines as long as their dose has been stable for at least three months, or they can be new to treatment. The study will carefully exclude anyone with other brain conditions, severe health problems, or certain medical risks to ensure safety. If you join, you can expect to receive either the surgery plus usual care or just usual care, and your memory and thinking abilities will be checked regularly over 12 months to see how well the treatment works. The study is not yet enrolling participants but aims to provide new options for managing Alzheimer’s disease in the future.

Gender

ALL

Eligibility 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) of 2 or 3.
• • 4. Mini-Mental State Examination (MMSE) score 5-20.
• • 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.