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Cervical Lymphatico-Venous Bypass for Treatment of Alzheimer's Disease - Proof of Concept Study (CLyVeB-AD-1 Study)

RecruitingNAAges 50 Years - 80 YearsAllVincent Tay Khwee Soon
NCT06965062 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Alzheimer's disease (AD), one of the most common causes of dementia in Singapore and the developed world, is a neurodegenerative disorder with high socioeconomic impact. Accumulation of neurotoxic proteins (ie. amyloid, tau) are purported to lead to neuroinflammation, synaptic dysfunction and cognitive decline. The available pharmacotherapy provide limited symptomatic control, modest effect on disease progression with significant risk of side effects. Patients with AD eventually run out of effective pharmacotherapy and deteriorate. Recent evidence implicated the glymphatic system, meningeal lymphatics of the brain, and downstream drainage to the cervical lymphatic system in the accumulation of neurotoxic proteins in AD. This presented the opportunity for extra-cranial intervention, and has since been demonstrated in preclinical models. Based on these development, Xie and colleagues pion

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of mild-moderate Alzheimer's disease (based on NIA-AA criteria); * Mini-Mental State Examination (MMSE) score 10-22; * Both participants and caregiver are able to understand English or Mandarin * Ability to provide informed consent or have a legally authorised representative to provide informed consent; * Good family support for post-treatment care and rehabilitation; * Fit for general anaesthesia/deep sedation and surgery (ASA 1-2; excluding the diagnosis of Alzheimer's Disease). Exclusion Criteria: * Cognitive decline due to prior infection or autoimmune diseases; * History of major cerebrovascular events or significant cardiovascular diseases; * Inability to have the head turned passively by at least 40 degrees; * Previous neck lymph node surgery or irradiation; * Active infection or malignancy; * Any contraindications to surgery or lumbar puncture * Any contraindication to MRI/PET scan (eg. metallic implant that are not MRI-safe, known radiotracer allergy) * Experimental Alzheimer's Disease treatment within the past 6 months. • Current use of monoclonal antibodies treatment (eg. lecanemab/donanemab)
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What it tests

  • Deep cervical lymph node to venous bypass (DCLNV-BP)
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Where

1 site
Changi General Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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