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Not yet recruiting NCT06978946

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

No phase Interventional Alzheimer Disease Lewy Body Dementia (LBD) Frontotemporal Dementia (FTD) Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Cervical Lymphaticovenous Anastomosis(DLVA).
Who it may be relevant to
Registry conditions: Alzheimer Disease, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Dementia. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Efficacy and Safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in Moderate-to-Severe Neurodegenerative Dementia

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • Severity of dementia [Time frame: preoperative day 3，postoperative day 3、month 3、month 6、month12]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06978946 · DLVA-NDD-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗