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 range50 Years – 80 Years
SexALL
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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
✕. 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;
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
✕. 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);