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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 59
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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).
- •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.
- •Alcohol or drug abuse/dependence within recent 1 year.
- •Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
- •Contraindications for PET examination.
- •Other conditions judged by investigators unsuitable for enrollment.
研究者
Rong Hu, MD
MD, Professor
Southwest Hospital, China