About this trial
The main pathological mechanism of Alzheimer's Disease (AD) is the abnormal deposition of amyloid-beta (Aβ) and tau proteins in the brain. Recent studies indicate that these two proteins are primarily cleared through the glymphatic system-meningeal lymphatic vessels-deep cervical lymphatic vessels pathway. Lymphatic circulation disorders in elderly patients can directly lead to the abnormal deposition of these proteins. Deep cervical lymphovenous bypass can improve lymphatic circulation and effectively treat lymphedema. This project aims to verify the effectiveness of 'deep cervical lymphovenous bypass' in treating AD, offering a new surgical treatment method to improve cognitive impairment and the quality of life for AD patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The age ranged from 60 to 80 years, and the time from initial diagnosis to enrollment was more than 12 months
The estimated survival time is more than 12 months;
The clinically diagnosed patients with mild to severe Alzheimer's Disease;
The imaging examination has the correlation diagnosis evidence;
Disqualifiers
Complicated with other severe systemic underlying diseases;
Unable to tolerate general anesthesia;
The pregnant women;
Recent severe infection or infectious diseases within 4 weeks;
Trial design
Single group
Treatments tested in this trial
Deep cervical Lymphovenous Bypass
Procedure/SurgeryDeep cervical lymph-vein bypass surgery, connecting deep cervical lymph input vein vessel
Treatment groups
Trial outcomes
Primary outcomes
PET scan
Detecting changes in the brain's amyloid and tau protein burden before and after surgery.Aβ/tau positron emission tomography (PET) facilitates spatial visualization and quantitative analysis of abnormal protein accumulations in the brains of Alzheimer's disease (AD) patients, offering objective imaging data crucial for early diagnosis, disease assessment, post-operative efficacy monitoring, and prognostic evaluations. Interpretations and quantitative assessments of Aβ-PET images are primarily focused on four cerebral regions: the lateral temporal cortex, frontal lobe, posterior cingulate gyrus/precuneus, and parietal lobe, aiding in the diagnosis of AD. The deposition of tau protein is positively correlated with disease severity; it initially accumulates predominantly in the medial temporal lobe and extends to neocortical regions during the middle and late stages. Tau PET is instrumental for monitoring disease progression and evaluating treatment outcomes.
The Alzheimer's Disease Comprehensive Rating Scale (iADRS)
The change in iADRS scores before and after surgery. The iADRS is a simple linear combination of two recognized, treatment-sensitive, and widely accepted measures of Alzheimer's Disease (AD), namely the AD Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL), used for the measurement of core assessment domains in AD.The total score of ADAS-Cog ranges from 0 to 70, with higher scores indicating greater cognitive impairment. The total score of ADCS-iADL ranges from 0 to 78, assessing the ability to perform complex activities of daily living, with higher scores indicating greater functional impairment.
Secondary outcomes
Plasma Aβ1-42 and plasma p-tau181
Elevated preoperatively, postoperatively the indicators have decreased, with reference values being plasma Aβ1-42 ≤ 110.00 pg/mL; plasma p-tau181 ≤ 30.00 pg/mL.
Mini-Mental State Examination(MMSE)
The MMSE score is a widely used brief cognitive assessment scale for the rapid screening of cognitive functions, especially dementia. It encompasses various aspects such as orientation to time, place, immediate memory, attention and calculation, delayed memory, language, and visuospatial abilities.The total score of MMSE is 0-30,with higher scores mean a better outcome.
Montreal Cognitive Assessment(MoCA)
The MoCA (Montreal Cognitive Assessment) score is a specialized tool for the rapid screening of Mild Cognitive Impairment (MCI). The MoCA scale includes tests across various cognitive domains, such as attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation, and orientation, comprising a total of 11 examination items. The total score of the MoCA scale is 30 points, with a score of 26 points or above typically considered to indicate normal cognitive function, while a score below 26 may suggest the presence of cognitive dysfunction.
Sponsors and contacts
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