Actively Recruiting
Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)
Led by Beijing Tiantan Hospital · Updated on 2026-05-12
376
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Alzheimer's Disease (AD) is a common neurodegenerative disorder primarily affecting older adults. This trial investigates the safety and effectiveness of a surgical procedure called deep cervical lymphatic venous anastomosis (DC-LVA) combined with usual care compared to usual care alone in reducing cognitive decline measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) over 12 months in patients with moderate-to-severe AD. The study also examines changes in brain amyloid beta levels using PET imaging. Participants will be randomly assigned to receive either DC-LVA plus usual care or usual care alone. The DC-LVA procedure involves connecting deep cervical lymphatic tissue to neck veins to improve lymphatic drainage, guided by fluorescence imaging. Usual care includes medications for cognitive support if already being used. After 12 months, an open-label extension allows control group participants to opt for DC-LVA, with follow-up visits every three months through month 24. During the study, participants will attend face-to-face visits at baseline, 7 days or hospital discharge, and at 3, 6, 9, and 12 months after randomization. Researchers will assess cognitive function with standardized scales and analyze biomarkers in blood, saliva, urine, cerebrospinal fluid, and brain imaging, including MRI and metabolic markers. Safety will be monitored by recording adverse events. The total active study period spans up to 24 months including the extension phase.
CONDITIONS
Brief Title
Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years, male or female
- Diagnosed with Alzheimer's Disease based on NIA-AA criteria
- Moderate-to-severe AD dementia with Clinical Dementia Rating Scale Global Score of 1 or higher
- Mini-Mental State Examination score between 10 and 20
- Alzheimer's Disease duration of more than 6 months
- Stable dose of approved AD treatment for at least 3 months before baseline, or treatment-nafve
- Have an identified caregiver who supports the participant and spends at least 8 hours per week with them
- Signed informed consent from the participant or relative and caregiver
You will not qualify if you...
- Any neurological condition other than AD affecting cognition (e.g., stroke, Parkinson's disease, epilepsy, brain tumors, brain injury, infections, metabolic encephalopathy)
- Other causes of dementia such as vascular dementia or hereditary small vessel disease
- Severe stenosis (70% or more) in middle cerebral artery or internal carotid artery
- Primary psychiatric disorders other than AD-related symptoms (e.g., schizophrenia, major depression, bipolar disorder)
- Severe neurological deficits affecting movement, language, vision, hearing, or consciousness
- History of drug or alcohol abuse or dependence
- History of malignant tumors or prior head and neck radiotherapy or surgery
- Major surgery or severe trauma within past 30 days
- Life-threatening conditions with expected survival under 2 years
- Contraindications to head MRI including implanted devices
- Severe heart, lung, liver, kidney, or other organ disease preventing anesthesia or procedure tolerance
- Severe bleeding disorders or conditions affecting blood clotting
- Need for long-term antithrombotic use with inability to discontinue before surgery
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >95 mmHg)
- Co-infection with HIV, syphilis, or uncontrolled infections
- Use of other investigational drugs/devices within 30 days or current participation in other interventional studies
- Pregnancy, lactation, potential pregnancy, or plans for pregnancy during study
- Immediate family members of investigators or staff or those with potential conflicts of interest related to the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants in the intervention group undergo bilateral deep cervical lymphatic venous anastomosis (DC-LVA) through a cervical incision as part of the treatment.
1 visit (in-person surgical procedure)
Duration - 12 months
Participants receive either DC-LVA plus usual care or usual care alone. Usual care includes medications to improve cognitive function as appropriate.
Face-to-face visits at baseline, 7 days (or hospital discharge), 3 months, 6 months, 9 months, and 12 months after randomization
Duration - 12 months
Participants are followed during a 12-month open-label extension phase with visits every 3 months after the initial 12 months. Control group participants may choose to receive DC-LVA during this phase.
Quarterly visits every 3 months until 24 months after randomization
Trial Site Locations
Total: 9 locations
1
Dongguan Chashan Hospital
Dongguan, Guangdong, China
Actively Recruiting
2
Guangdong Second People's Hospital
Guangdong, Guangzhou, China, 510000
Actively Recruiting
3
Zhengzhou Central Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
4
First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Active, Not Recruiting
5
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China, 250000
Actively Recruiting
6
Shandong Provincial Third Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
7
Jining First People's Hospital
Jining, Shandong, China, 272000
Actively Recruiting
8
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Actively Recruiting
9
Beijing Tiantan Hopital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
Research Team
Y
Yuesong Pan
Y
Yilong Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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