Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD Registry)
NCT ID: NCT07058129
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
814 participants
OBSERVATIONAL
2025-07-30
2029-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Cervical Lymphaticovenous Anastomosis Surgery for Moderate-to-Advanced Dementia Patients
NCT06978946
Clinical Study on Deep Cervical Lymphatic Trunk Decompression Combined With Mid-Cervical Deep Lymph Node-External Jugular Vein Anastomosis for Alzheimer's Disease Treatment
NCT06936514
Clinical Study on Lymphaticovenous Anastomosis（LVA） for the Treatment of Alzheimer's Disease（AD）
NCT06918145
A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease
NCT07060391
Cervical Lymphatico-Venous Bypass for Treatment of Alzheimer's Disease - Proof of Concept Study (CLyVeB-AD-1 Study)
NCT06965062
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in improve the cognitive function of AD patients at 12 months, and to identify subgroups asscociated with the treatment outcome.
This cohort is a multicenter, prospective, registry. A total of 814 patients received DC-LVA treatment in 40 centers from China will be enrolled. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3 months ± 7 days, 6months ± 15 days, 12 month ± 15 days, 18 month ± 15 days, and 24 month ±15 days.
The change of clinical dementia rating-sum of boxes (CDR-SB) score, Neuropsychiatric Inventory (NPI) score, Activities of Daily Living (ADCS-ADL) score, Caregiver Burden (ZCI-AD) score, Mini-Mental State Examination (MMSE) score, AD Assessment Scale-Cognitive Subscale (ADAS-cog13) score at 3, 6, 12, 18, 24 months, and the change of brain amyloid burden evaluated by Aβ PET-CT centiloid value at 12 months will be measured.
The changes of CDR-SB score will be analyzed using a repeated measures mixed-effects model. Least squares means will be used to estimate the levels at each time point, and the mean difference with 95% confidence intervals will be calculated. Safety outcomes will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
In exploratory outcome measures, we will analyse the AD associated biomarkers in lymphatic tissue during the surgery, the change of fluid biomarkers (peripheral blood, saliva, urine,and cerebrospinal fluid AD associated biomarkers), the change of MRI brain volumes (total brain volume, hippocampal volume, lateral ventricle volume), the change of glymphatic function index(DTI-ALPS), the change of MRS metabolic markers (N-Acetylaspartate, Creatine, Choline, Lactate, Glutamate and Glutamine, myo-Inositol), and the change of artificial intelligence-assisted oculomotor/gait measurements during 12 months of follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deep cervical lymphatic venous anastomosis
The intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). Through cervical incision, the deep cervical lymphatic tissue is anatomically dissected and anastomosed with the venous system of the neck. Under indocyanine green (ICG) navigation, the flow of lymphatic fluid into the vein could be observed via ICG tracing fluorescence after surgery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed with AD according to the NIA-AA criteria.
3. Patients who have received DC-LVA treatment;
4. Signed informed consent (by the subject or their relative, and caregiver)
Exclusion Criteria
2. The subject lacks a stable and reliable caregiver to accompany with them during entire study follow-up visits.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Tiantan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
yilong Wang
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hopital, Capital Medical University
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KY2025-090-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.