Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease

Starting soon · Not applicable

Conditions studied: Alzheimer's Disease

In brief

This is a multicenter, prospective, open-label, endpoint-blinded randomized controlled clinical study. We aim to evaluate the safety and efficacy of deep cervical lymphovenous anastomosis (LVA) combined with routine treatment for patients with moderate Alzheimer's disease, compared with routine treatment alone. A total of 296 eligible participants aged 50 to 80 years with moderate Alzheimer's disease will be enrolled and randomly divided into two groups at a 1:1 ratio. One group will receive deep cervical lymphovenous anastomosis plus standard routine treatment, while the other group will only receive standard routine treatment for Alzheimer's disease. All participants will be followed up for 12 months after randomization. We will assess cognitive function using MMSE and CDR-SB scales, evaluate caregiver burden via ZBI scale, and detect changes in Alzheimer's disease related biomarkers including blood amyloid-beta and tau protein, as well as Aβ-PET imaging indicators. The main goal is to observe whether this surgical procedure can improve patients' neurological function and clear abnormal protein deposits in the brain, and confirm its long-term safety. This study strictly follows ethical principles. Every participant or their legal representative will sign a written informed consent before enrollment. During the whole study period, we will closely monitor all adverse events to ensure the safety of participants.

Key facts

Study ID

NCT07658430

Run by

Southwest Hospital, China

People needed

296

Starts

2026-07-01

Expected to finish

2029-06-30

Last updated by the study team

2026-06-22

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 50 to 80 years old, male or female.
• Clinically diagnosed with moderate probable Alzheimer's disease according to the NIA-AA criteria.
• Baseline Mini-Mental State Examination (MMSE) score between 10 and 20 points.
• Clinical cognitive decline duration of at least 6 months.
• Stable routine anti-dementia drug treatment for more than 6 months without obvious clinical improvement.
• Able to complete neuropsychological scale assessments, blood biomarker detection and Aβ-PET examination.
• Have a reliable caregiver who can accompany follow-up visits and assist in completing evaluations.
• The participant or legal surrogate voluntarily signs the written informed consent.

You may not qualify if…

• Severe cardiac, hepatic, renal, respiratory or hematopoietic system dysfunction unable to tolerate surgery or anesthesia.
• A history of intracranial surgery, severe craniocerebral trauma, stroke, brain tumor or other central nervous system diseases.
• Other types of dementia, including vascular dementia, frontotemporal dementia, Lewy body dementia, or mixed dementia.
• Psychiatric disorders requiring long-term medication that may affect cognitive assessment results.
• Contraindications for PET imaging or contrast agent allergy.
• Active infection, malignant tumor or severe wasting disease.
• Pregnancy or breastfeeding status.
• Participation in other interventional clinical trials within 3 months before enrollment.
• Poor compliance or inability to complete scheduled follow-up.
• Any other condition judged inappropriate for enrollment by the investigator.

Where it is running

• The First Affiliated Hospital of Army Medical University (Southwest Hospital) — Chongqing, Chongqing Municipality, China

Full record on ClinicalTrials.gov

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