NCT07669272Not yet recruiting
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
A Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function. This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE \< 10). All patients receive bilateral DCLVA plus routine medication. The primary endpoint is change of CDR-SB score at 12 months post-operation. Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value. This study aims to verify the efficacy and safety of DCLVA for severe AD.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- First submitted
- 21 Jun 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Southwest Hospital, China
- Diseases
- Alzheimer disease
- NCT number
- NCT07669272
What you commit to
- Study type: Interventional
- Planned participants: 59
- From 1 Oct 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse/dependence within recent 1 year.
Other illness
- Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
- Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
- Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
- History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
- Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
- Other conditions judged by investigators unsuitable for enrollment.
Lab values
- Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST \> 3 times upper limit of normal); severe renal insufficiency (eGFR \< 30ml/min).
Other
- Contraindications for PET examination.
Who the study is looking for
- Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
- Aged 50 to 80 years (inclusive) at the time of signing informed consent.
- Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score \< 10 points.
- Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
- No clinical improvement after more than 6 months of standardized drug treatment.
- Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits.
- Able to complete scale assessments and examinations independently or with companion assistance.
- Voluntarily comply with study procedures, examinations and surgical treatment.
- Patient or legal representative can sign written informed consent and abide by trial requirements.
- Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.