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

Launched by RENJI HOSPITAL · May 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of surgery called Deep Cervical Lymphaticovenous Anastomosis (DLVA) to see if it can help improve the health of patients aged 50 to 80 who are experiencing moderate to advanced dementia, including those with Alzheimer's disease, Parkinson's disease dementia, Lewy body dementia, and frontotemporal dementia. The goal is to find out how effective and safe this surgery is. Participants will undergo the surgery and then have several follow-up tests, such as brain scans and cognitive assessments, to monitor their progress and better understand how the surgery works.

To be eligible for this trial, participants must be between 50 and 80 years old and have been diagnosed with one of the mentioned types of dementia. They should have moderate to severe cognitive impairment, as measured by standard tests, and must be on stable medication for at least a month. However, those with other specific medical conditions or types of dementia not included in the study will not be able to participate. If you or a loved one meet these criteria and are interested, please keep an eye out for updates, as the trial is not yet recruiting participants.

Gender

ALL

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.