This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
Age 50-80 years, male or female.
Diagnosed with AD according to NIA-AA criteria.
Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
Mini-Mental State Examination (MMSE) score 10-20.
Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial infections, metabolic encephalopathy, etc.
Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.
Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.
Parallel
DC-LVA treatment plus usual care
Procedure/SurgeryThrough cervical incision, the deep cervical lymphatic tissue is anatomically dissected and anastomosed with the venous system of the neck. Under indocyanine green (ICG) navigation, the flow of lymphatic fluid into the vein could be observed via ICG tracing fluorescence after surgery.
Usual care
Other interventionThe usual care group includes patients who were not using or were currently using medications for improving cognitive function.
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after randomization
The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score
Clinician's Interview-Based Impression of Change plus caregiver input score (CIBIC-plus, 1-7 score, higher scores mean a worse outcome)
The Change of Neuropsychiatric Inventory Score
Neuropsychiatric Inventory Score (NPI, 0-144 score, higher scores mean a worse outcome)
The Change of Aβ PET-CT Centiloid value
The change of Aβ PET-CT Centiloid value at 12 months
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score
Zarit Caregiver Interview of Alzheimer's Disease Score (ZCI-AD, 0-88 score, higher scores mean a worse outcome)
The change of Clinical Dementia Rating-Sum of Boxes score during the open-label extension phase
Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score during the open-label extension phase
Clinician's Interview-Based Impression of Change plus caregiver input score (CIBIC-plus, 1-7 score, higher scores mean a worse outcome)
The Change of Neuropsychiatric Inventory Score during the open-label extension phase
Neuropsychiatric Inventory Score (NPI, 0-144 score, higher scores mean a worse outcome)
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score during the open-label extension phase
Zarit Caregiver Interview of Alzheimer's Disease Score (ZCI-AD, 0-88 score, higher scores mean a worse outcome)
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