Actively Recruiting
Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)
Led by Beijing Tiantan Hospital · Updated on 2026-05-12
376
Participants Needed
9
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
CONDITIONS
Official 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
- Diagnosis of Alzheimer's Disease according to NIA-AA criteria
- Moderate-to-severe Alzheimer's Disease dementia with Clinical Dementia Rating Scale Global Score of 1 or higher
- Mini-Mental State Examination (MMSE) score between 10 and 20
- Alzheimer's Disease course longer than 6 months
- If on approved Alzheimer's treatment, stable dose for at least 3 months before baseline; treatment-na�efve patients allowed
- Identified caregiver able to support participant and spend at least 8 hours per week with them
- Signed informed consent from participant or relative and caregiver
You will not qualify if you...
- Other neurological conditions affecting cognition such as stroke, Parkinson's disease, epilepsy, brain tumors, traumatic brain injury, infections, or metabolic encephalopathy
- Other causes of dementia including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or other etiologies
- Severe stenosis (70% or more) in middle cerebral artery or internal carotid artery
- Primary psychiatric disorders like schizophrenia, major depressive disorder, bipolar disorder, or schizoaffective disorder
- Severe neurological deficits affecting movement, language, vision, hearing, or consciousness, or conditions preventing cognitive assessments
- History of drug or alcohol abuse or dependence
- History of malignant tumors or prior radiotherapy or surgery involving head and neck
- Major surgery or severe trauma within past 30 days
- Life-threatening conditions with expected survival under 2 years
- Contraindications to head MRI such as pacemakers or metal implants
- Severe heart, lung, liver, kidney, or other organ diseases impairing anesthesia or surgery tolerance
- Severe bleeding risk including low platelet count, recent heparin therapy, or warfarin use with high INR
- Need for long-term antithrombotic medications that cannot be stopped before surgery
- Uncontrolled persistent high blood pressure (systolic >160 mmHg or diastolic >95 mmHg)
- Co-infection with HIV or Treponema pallidum or uncontrolled infections
- Use of other investigational drugs or devices within 30 days before consent or participation in other interventional studies
- Pregnancy, lactation, potential pregnancy, or plans for pregnancy during study
- Immediate family of investigator or staff with conflict of interest related to the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yilong Wang
CONTACT
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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