Clinical Study on Deep Cervical Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lym… (NCT06936514) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Study on Deep Cervical Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease Treatment
China45 participantsStarted 2025-01-08
Plain-language summary
The aim of this study is to evaluate the feasibility, safety, and efficacy of bilateral deep cervical lymphatic trunk decompression combined with mid and deep cervical lymph node-extracervical vein anastomosis in the treatment of patients with Alzheimer's disease. The study seeks to explore new treatment options that may improve the quality of life for patients with Alzheimer's disease.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 50-80 years;
. Meet the diagnostic criteria for AD in the Revised Criteria for the Diagnosis and Staging of Alzheimer's Disease (2024) published by the National Institute Aging and Alzheimer's Association (NIA-AA);
. Presence of moderate-to-severe cognitive impairment with a Clinical Dementia Rating (CDR) score ≥2, and Mini-Mental State Examination (MMSE) score of \< 20;
. Stable use of medication for ≥1 month and no planned change in medication within 3 months of randomisation;
. The patients and their families had been informed of the purpose, significance, expected effects and potential risks of the study and voluntarily participated in the study by providing biological samples and signing an informed consent form.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves a surgical procedure to decompress lymphatic vessels in the neck and create a connection between lymph nodes and a vein — how major is this surgery, and what are the specific risks I should know about before even considering it?
2The trial is listed as 'enrolling by invitation only' — how would someone get referred or considered for this study, and is that something worth pursuing given my current stage of Alzheimer's disease?
3Since this trial doesn't have a traditional phase number, what does that mean for how much is already known about whether this lymphatic surgery approach is safe and effective for Alzheimer's patients?
4The study is measuring cognitive changes using tools like the MoCA, MMSE, and ADAS-Cog13 — over what time period would I need to come in for assessments, and how would that schedule realistically fit into my life and care situation?
5Before considering an experimental surgical approach like this, are there standard treatments or other clinical trials I should try first that might have a stronger evidence base behind them?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Alzheimer's disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
Timeframe: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
2
Change in Montreal Cognitive Assessment (MoCA)
Timeframe: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
3
Change in Mini-mental State Examination (MMSE)
Timeframe: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
4
Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB)
Timeframe: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
5
Change in Clinical Dementia Rating Scale global score (CDR-GS)
Timeframe: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Trial details
NCT IDNCT06936514
SponsorOriental Neurosurgery Evidence-Based-Study Team
. Dementia caused by other reasons: vascular dementia, central nervous system infections (e.g. HIV, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's chorea and Parkinson's disease, dementia with Lewy bodies, dementia due to traumatic brain injury, other physical and chemical factors (e.g. drug intoxication, alcohol intoxication, carbon monoxide intoxication, etc.), important physical diseases (e.g. hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupying lesions (e.g. subdural haematoma, brain tumour), endocrine system lesions (e.g. thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
. Presence of current serious or unstable medical conditions, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except for cognitive impairment of AD origin), psychiatric, immunological or haematological disorders, and any other condition which, in the opinion of the investigator, may affect the results of the analyses in this study; or a life expectancy of \<24 months;
. Presence of a history of cancer within 5 years, with the exception of non-metastatic basal cell and/or squamous cell carcinoma of the skin, cervical carcinoma in situ, non-progressive prostate cancer, or other cancers with a low risk of recurrence or spread;
. Subjects with a current diagnosis of any primary psychiatric disorder other than cognitive impairment of AD origin, which requires exclusion if, in the opinion of the Investigator, the presence of the psychiatric disorder or symptom may interfere with interpretation of the effects of the LVA, interfere with cognitive assessment, or interfere with the subject's ability to complete the study. Exclusion is required for subjects with a history of schizophrenia or other chronic psychiatric illness;
. Subjects who, in the judgement of the investigator, are actively suicidal and therefore considered to be at significant risk of suicide;
. Illiteracy or insufficient education to complete the scale assessment;
. A history of alcohol or drug abuse (other than a history of smoking) in the 2 years prior to the screening visit;
. A clinically significant history of multiple or severe drug allergies, significant atopic sensitivities, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme, linear IgA dermatosis, toxic epidermal necrolysis-relaxation, and/or exfoliative dermatitis);