The aim of this study is to evaluate the feasibility, safety, and efficacy of bilateral deep cervical lymphatic trunk decompression combined with mid and deep cervical lymph node-extracervical vein anastomosis in the treatment of patients with Alzheimer's disease. The study seeks to explore new treatment options that may improve the quality of life for patients with Alzheimer's disease.
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by memory loss, cognitive impairment, and behavioral changes, ultimately leading to the inability of patients to perform daily activities independently. Despite the availability of various pharmacological treatments aimed at alleviating the progression of the disease, current therapeutic approaches are unable to effectively delay or reverse the course of AD. Therefore, the treatment of Alzheimer's disease remains a significant challenge in the global medical community. This issue is particularly pressing in patients with moderate to severe AD, as existing therapies have limited efficacy, creating a critical need for novel treatment strategies. The discovery of the brain's lymphatic system has opened new avenues for the treatment of neurodegenerative diseases, including Alzheimer's disease. Recent studies have shown that the meningeal lymphatic vessels play a crucial role in clearing waste products from the brain, including neurotoxins such as amyloid-beta, which accumulate in patients with AD. Dysfunction of this lymphatic drainage system has been implicated in the pathogenesis of Alzheimer's disease. This insight has spurred interest in enhancing lymphatic drainage as a potential therapeutic approach for AD. Lymphatic-venous anastomosis (LVA) is a surgical technique traditionally used to treat lymphedema and other lymphatic drainage disorders. It involves surgically connecting lymphatic vessels to nearby veins, allowing lymph fluid to flow directly into the venous system. Studies have suggested that LVA may help improve lymphatic drainage in the brain and potentially reduce the accumulation of harmful substances associated with Alzheimer's disease, thereby slowing disease progression. This research aims to provide valuable insights into the potential of enhancing brain lymphatic drainage as a therapeutic strategy for Alzheimer's disease, potentially leading to significant breakthroughs in its treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
This intervention involves a surgical approach that combines bilateral cervical deep lymphatic trunk decompression with mid-cervical deep lymph node-external jugular vein anastomosis (LVA) to enhance lymphatic drainage in Alzheimer's Disease (AD) patients. The aim is to reduce the accumulation of neurotoxic substances in the brain, potentially improving cognitive function by facilitating waste clearance via the lymphatic system. The procedure is intended to restore normal lymphatic flow, potentially slowing disease progression in AD patients who have moderate to severe cognitive impairment.
General Hospital of Tianjin Medical University, 154 Anshan Road, Heping District, Tianjin, China
Tianjin, China
Change in Alzheimer's disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14)
The Alzheimer's disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog 14) will be used to evaluate the general cognitive function. ADAS-Cog 14 ranges from 0 to 90, and higher value represents a worse outcome.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Change in amyloid deposit in brain
Change from baseline as measured by amyloid positron emission tomography (PET) scan using centiloids. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline.
Time frame: Baseline and 3 months after surgery
Change in Clinical Dementia Rating Scale sum of the boxes (CDR-SB)
The Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Change in Mini-mental State Examination (MMSE)
The Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Change in Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Change in Hamilton Depression Scale (HAMD)
The Hamilton Depression Scale (HAMD) will be used to evaluate the general depression status. HAMD ranges from 0 to 52, and higher value represents a better outcome.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Chang in Hamilton Anxiety Scale (HAMA)
The Hamilton Anxiety Scale (HAMA) will be used to assess general anxiety status.The HAMA ranges from 0 to 56, with higher values resulting in better outcomes.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
Changes in AD-related biomarkers
Change from baseline in blood levels of Aβ42, Aβ40, Aβ42/40, pTau217, and pTau181.
Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months.
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