Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease

NCT07658430 | Not Yet Recruiting DMC

• 2 other identifiers: KY2026125(A)KY2026125
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; deep cervical lymphovenous anastomosis; cognitive function; randomized controlled trial; multicenter study

Outcome Measures

Primary Outcomes (1)

• Change in CDR-SB score from baseline to 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.

  12 months after randomization

Secondary Outcomes (4)

• Change in CDR-SB score at 1 month and 6 months after randomization

  1 month, 6 months after randomization

• Change in MMSE score

  1 month, 6 months, 12 months after randomization

• Change in Zarit Burden Interview (ZBI) score

  1 month, 6 months, 12 months after randomization

• Change in Aβ-PET Centiloid value

  12 months after randomization

Study Arms (2)

Intervention Group (Surgery plus routine treatment)

EXPERIMENTAL

Participants undergo bilateral deep cervical lymphovenous anastomosis (LVA), combined with standard routine drug treatment for moderate Alzheimer's disease.

Procedure: Deep cervical lymphovenous anastomosis (LVA); Other: Routine Treatment

Control Group (Routine treatment only)

ACTIVE COMPARATOR

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

Other: Routine Treatment

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.

Intervention Group (Surgery plus routine treatment)

Routine Treatment OTHER

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

Control Group (Routine treatment only); Intervention Group (Surgery plus routine treatment)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rong Hu, Dr

CONTACT

+8602368765911; huchrong@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, care providers and investigators are aware of group allocation. Besides outcomes assessors, statistical analysts are also masked throughout the trial to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Chief Physician, Neurosurgeon

Model Details: Two parallel groups are set in this trial. Participants are randomly allocated to either the surgical combined with routine treatment group or the routine treatment alone group at a 1:1 ratio. No crossover or group switching will occur during the entire study period.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)