Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease (NCT07658430) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease
China296 participantsStarted 2026-07-01
Plain-language summary
This is a multicenter, prospective, open-label, endpoint-blinded randomized controlled clinical study. We aim to evaluate the safety and efficacy of deep cervical lymphovenous anastomosis (LVA) combined with routine treatment for patients with moderate Alzheimer's disease, compared with routine treatment alone.
A total of 296 eligible participants aged 50 to 80 years with moderate Alzheimer's disease will be enrolled and randomly divided into two groups at a 1:1 ratio. One group will receive deep cervical lymphovenous anastomosis plus standard routine treatment, while the other group will only receive standard routine treatment for Alzheimer's disease.
All participants will be followed up for 12 months after randomization. We will assess cognitive function using MMSE and CDR-SB scales, evaluate caregiver burden via ZBI scale, and detect changes in Alzheimer's disease related biomarkers including blood amyloid-beta and tau protein, as well as Aβ-PET imaging indicators. The main goal is to observe whether this surgical procedure can improve patients' neurological function and clear abnormal protein deposits in the brain, and confirm its long-term safety.
This study strictly follows ethical principles. Every participant or their legal representative will sign a written informed consent before enrollment. During the whole study period, we will closely monitor all adverse events to ensure the safety of participants.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 50 to 80 years old, male or female.
* Clinically diagnosed with moderate probable Alzheimer's disease according to the NIA-AA criteria.
* Baseline Mini-Mental State Examination (MMSE) score between 10 and 20 points.
* Clinical cognitive decline duration of at least 6 months.
* Stable routine anti-dementia drug treatment for more than 6 months without obvious clinical improvement.
* Able to complete neuropsychological scale assessments, blood biomarker detection and Aβ-PET examination.
* Have a reliable caregiver who can accompany follow-up visits and assist in completing evaluations.
* The participant or legal surrogate voluntarily signs the written informed consent.
Exclusion Criteria:
* Severe cardiac, hepatic, renal, respiratory or hematopoietic system dysfunction unable to tolerate surgery or anesthesia.
* A history of intracranial surgery, severe craniocerebral trauma, stroke, brain tumor or other central nervous system diseases.
* Other types of dementia, including vascular dementia, frontotemporal dementia, Lewy body dementia, or mixed dementia.
* Psychiatric disorders requiring long-term medication that may affect cognitive assessment results.
* Contraindications for PET imaging or contrast agent allergy.
* Active infection, malignant tumor or severe wasting disease.
* Pregnancy or breastfeeding status.
* Participation in other interventional clinical trials within 3 months before enrollment.
* Poor compliance or inability to complete sch…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in CDR-SB score from baseline to 12 months after randomization