Status:
RECRUITING
Cervical Lymphatico-Venous Bypass for Treatment of Alzheimer's Disease - Proof of Concept Study (CLyVeB-AD-1 Study)
Lead Sponsor:
Vincent Tay Khwee Soon
Collaborating Sponsors:
Changi General Hospital
Singapore General Hospital
Conditions:
Alzheimer Disease
Dementia Alzheimer Type
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06965062
Start Date
April 1 2025
End Date
March 31 2030
Last Update
May 11 2025
Active Locations (1)
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1
Changi General Hospital
Singapore, Singapore