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

Launched by VINCENT TAY KHWEE SOON · May 1, 2025

Keywords

ClinConnect Summary

The CLyVeB-AD-1 study is exploring a new treatment approach for Alzheimer's disease (AD), which is a common cause of dementia. This trial is looking at a procedure called deep cervical lymph node to venous bypass (DCLNV-BP), which aims to help remove harmful proteins that build up in the brain and may contribute to the disease. Researchers want to understand if this procedure is safe and if it can help improve thinking and daily functioning for people living with mild to moderate Alzheimer's.

To participate, individuals should be diagnosed with mild to moderate Alzheimer's disease and have a Mini-Mental State Examination (MMSE) score between 12 and 22. Participants must also be able to understand English or Mandarin and have support from family for care after treatment. The study is currently recruiting participants, and those who join can expect to undergo assessments that include brain scans and clinical evaluations to track their progress. This research could lead to new ways to treat Alzheimer's disease, which is important for many families facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of mild-moderate Alzheimer's disease (based on NIA-AA criteria);
• • Mini-Mental State Examination (MMSE) score 12-22;
• • 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:
• • Severe, confluent vascular burden on neuroimaging (eg. Fazeka 3);
• • 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)