Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Deep cervical lymphovenous anastomosis (LVA): A microsurgical lymphatic drainage procedure performed under operative microscope with ICG lymphography tracing. Bilateral deep cervical lymphovenous anastomosis is conducted to improve cerebral lymphatic clearance in patients with moderate Alzheimer's disease.

Routine Treatment: Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in CDR-SB score from baseline to 12 months after randomization — 12 months after randomization
  Change of Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 12 months compared with baseline, to evaluate overall cognitive and functional status of patients with moderate Alzheimer's disease.

Trial sites (1)

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