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

NCT06978946 | Not Yet Recruiting DMC

• 1 other identifier: DLVA-NDD-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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)

Keywords

Alzheimer Diseas; Lewy Body Dementia (LBD); Frontotemporal Dementia (FTD); Lymphaticovenous Anastomosis; Parkinsons Disease

Outcome Measures

Primary Outcomes (1)

• Severity of dementia

  Measured using the (Clinical Dementia Rating Scale - Sum of Boxes(CDR-SB).The CDR-SB is a quantitative tool used to assess the severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment), resulting in a total CDR-SB score ranging from 0 to 18. A score of 0 indicates no dementia, scores between 0.5 and 4.0 suggest very mild cognitive impairment or mild cognitive decline, 4.5 to 9.0 corresponds to mild dementia, 9.5 to 15.5 reflects moderate dementia, and scores between 16 and 18 represent severe dementia. In general, higher CDR-SB scores reflect greater cognitive and functional impairment, while lower scores indicate better cognitive performance and daily functioning.

  preoperative day 3，postoperative day 3、month 3、month 6、month12

Study Arms (5)

Control group

NO INTERVENTION

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

PDD surgical intervention group

EXPERIMENTAL

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

Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)

DLB surgical intervention group

EXPERIMENTAL

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

Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)

FTD surgical intervention group

EXPERIMENTAL

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

Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)

AD surgical intervention group

EXPERIMENTAL

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

Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)

Interventions

Deep Cervical Lymphaticovenous Anastomosis(DLVA) 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; DLB surgical intervention group; FTD surgical intervention group; PDD surgical intervention group

Eligibility Criteria

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

You may qualify if:

• Age between 50-80 years
• 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;
• Mini-Mental State Examination (MMSE)\<than 21, Montreal Cognitive Assessment (MoCA) score\<17, and Clinical Dementia Rating (CDR) score ≥2;
• Diagnosed by clinicians as having moderate to severe disease;
• On stable medication regimen for ≥1 month
• Signed informed consent and demonstrated good compliance

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200217, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Dementia; Parkinson Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Nan Zhi

CONTACT

＋86 18616878901; zhinan@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)