About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Deep Cervical Lymphovenous Anastomosis
- Routine Treatment