Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease

Sponsor
Southwest Hospital, China
Study ID
NCT07658430
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep cervical lymphovenous anastomosis (LVA) — PROCEDURE
    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 — OTHER
    Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.

Study Details

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 Dates

First listed
Jun 22, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
296 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group (Surgery plus routine treatment)
    Participants undergo bilateral deep cervical lymphovenous anastomosis (LVA), combined with standard routine drug treatment for moderate Alzheimer's disease.
  • Active Comparator: Control Group (Routine treatment only)
    Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.

Primary Outcome Measure

Change in CDR-SB score from baseline to 12 months after randomization [ Time Frame: 12 months after randomization ]

Central Contacts

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