Deep Cervical Lymphaticovenous Anastomosis Surgery for Moderate-to-Advanced Dementia Patients

NCT ID: NCT06978946

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2027-02-28

Brief Summary

This clinical trial aims to evaluate the clinical efficacy and safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in patients aged 50-80 with moderate to severe neurodegenerative dementia. Participants will undergo surgical treatment, followed by cognitive assessments, PET/MRI scans, lymph fluid/cerebrospinal fluid collection, and blood tests. Additionally, the study will perform an in-depth analysis of DLVA's therapeutic mechanisms using multimodal imaging and molecular biology experiments.

Conditions

Alzheimer Disease; Lewy Body Dementia (LBD); Frontotemporal Dementia (FTD); Dementia; Parkinsons Disease With Dementia (PDD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

This group served as the control group, consisting of AD patients who received no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PDD surgical intervention group

Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery.

Group Type: EXPERIMENTAL

Deep Cervical Lymphaticovenous Anastomosis(DLVA)

Intervention Type: PROCEDURE

This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck

DLB surgical intervention group

Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery.

Group Type: EXPERIMENTAL

Deep Cervical Lymphaticovenous Anastomosis(DLVA)

Intervention Type: PROCEDURE

This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck

FTD surgical intervention group

Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery.

Group Type: EXPERIMENTAL

Deep Cervical Lymphaticovenous Anastomosis(DLVA)

Intervention Type: PROCEDURE

This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck

AD surgical intervention group

Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery.

Group Type: EXPERIMENTAL

Deep Cervical Lymphaticovenous Anastomosis(DLVA)

Intervention Type: PROCEDURE

This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck

Interventions

Deep Cervical Lymphaticovenous Anastomosis(DLVA)

This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age between 50-80 years

2. AD participants meet the diagnostic criteria for Alzheimer's disease established by the National Institute on Aging and the Alzheimer's Association (NIA-AA); FTD participants meet the diagnostic criteria defined by the International Consortium on FTD; DLB participants meet the 2017 diagnostic criteria of the DLB Consortium; PDD participants meet the 2007 diagnostic criteria of the Movement Disorder Society or the 2011 Chinese diagnostic guidelines for PDD;

3. Mini-Mental State Examination (MMSE)<than 21, Montreal Cognitive Assessment (MoCA) score<17, and Clinical Dementia Rating (CDR) score ≥2;

4. Diagnosed by clinicians as having moderate to severe disease;

5. On stable medication regimen for ≥1 month

6. Signed informed consent and demonstrated good compliance

Exclusion Criteria

1. Dementia caused by other conditions, including: vascular dementia; central nervous system infections due to HIV, syphilis, etc.; Creutzfeldt-Jakob disease; Huntington's disease; traumatic brain injury-related dementia; dementia due to toxic or alcohol-related factors; major systemic diseases such as hepatic or pulmonary encephalopathy; subdural hematoma; endocrine disorders such as thyroid or parathyroid disease; vitamin deficiency; or any other cause of dementia.

2. Presence of severe or unstable medical conditions, including but not limited to cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (excluding cognitive impairment), psychiatric, immunological, or hematological disorders, or any other condition deemed by the investigator to potentially interfere with study results; or life expectancy < 24 months.

3. Current diagnosis of any primary psychiatric disorder other than cognitive impairment. If, in the investigator's opinion, the psychiatric condition or symptoms may interfere with cognitive assessment or the subject's ability to complete the study, exclusion is required. Subjects with a history of schizophrenia or other chronic psychotic disorders should also be excluded.

4. Contraindications to deep cervical LVA surgery, including left vagus nerve injury, severe infection at the surgical site, significant dysfunction of the heart, lungs, liver, kidneys, or other organ systems, a history of head and neck radiation therapy or surgery, preoperative anesthetic evaluation of ASA grade III or above, or inability to tolerate prolonged surgery.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Gang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Nan Zhi

Role: CONTACT

zhinan@renji.com

＋86 18616878901

Facility Contacts

Nan Zhi, MD

Role: primary

zhinan@renji.com

＋86 18616878901

Other Identifiers

DLVA-NDD-01

Identifier Type: -

Identifier Source: org_study_id