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A Single-Center, Prospective, Single-Arm Exploratory Study on Deep Cervical Lymphaticovenous Anastomosis for Improving Neurological Function in Alzheimer's Disease Patients

A Single-Center, Prospective, Single-Arm Exploratory Study on Deep Cervical Lymphaticovenous Anastomosis for Improving Neurological Function in Alzheimer's Disease Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089883
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

Surgical group:Deep Cervical Lymphaticovenous Anastomosis

Sponsors

Department of Neurosurgery, First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Meets the core clinical diagnostic criteria for probable Alzheimer's disease (AD) dementia as defined in the 2011 NIA-AA version (core criteria: a. insidious onset and progressive worsening, with impairment in work and daily living abilities; b. reported or observed history of clear cognitive deterioration, with impairment in work and daily living abilities; c. history and examination confirming early and significant cognitive impairment: amnestic and non-amnestic symptoms). 2.Age between 50 and 80 years old (inclusive), with patients under 65 years old requiring AD biomarker confirmation for diagnosis. 3.MMSE score = 10 points 4.No improvement in clinical symptoms after at least six months of drug therapy 5.No severe cardiac, hepatic, renal, or other systemic diseases. 6.Able to cooperate with all examinations and surgeries required for the study. 7.Voluntarily participating in this study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: Surgical contraindications, such as coagulation disorders (platelet count 100×109/L, INR > 1.4); Severe cardiopulmonary diseases and other surgical contraindications. For example, severe liver dysfunction with ALT or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30ml/min/1.73m2. Severe mental illness that prevents cooperation with the study. History of intracranial hemorrhage or craniocerebral trauma within the past year. History of internal bleeding, such as uncontrolled gastrointestinal, genitourinary, or respiratory tract bleeding; Myocardial infarction within the past 30 days; Current drug or alcohol abuse or dependence; Allergy to surgery-related medications, instruments, or contrast agents; Any disease in its terminal stage with an expected life expectancy of less than 180 days; Currently participating in other clinical trials (excluding: observational studies without intervention, natural history and/or epidemiological studies); Currently participating in other clinical trials (excluding: observational studies without intervention, natural history and/or epidemiological studies); Recent similar surgery or treatment; Other patients deemed unsuitable for inclusion upon evaluation.

Design outcomes

Primary

MeasureTime frame
ADL;

Secondary

MeasureTime frame
MMSE;MoCA;

Countries

China

Contacts

Public Contactrong hu

Department of Neurosurgery, First Affiliated Hospital of Army Medical University

huchrong@tmmu.edu.cn+86 151 2391 7123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026