Cervical lymphatic bypass for treating Alzheimer's disease
Cervical Lymphatico-Venous Bypass for Treatment of Alzheimer's Disease - Proof of Concept Study (CLyVeB-AD-1 Study)
This study is testing a new surgery to see if it can help people with mild to moderate Alzheimer's disease by improving the way the brain clears out harmful proteins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Changi General Hospital Academic / other |
| Drugs / interventions | lecanemab, donanemab |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06965062 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel surgical approach called deep cervical lymph node to venous bypass (DCLNV-BP) aimed at treating Alzheimer's disease by addressing the accumulation of neurotoxic proteins in the brain. The procedure is based on recent findings regarding the glymphatic system and its role in neuroinflammation and cognitive decline. Participants diagnosed with mild to moderate Alzheimer's disease will undergo this intervention to evaluate its safety and potential efficacy. The study aims to provide an alternative to existing pharmacotherapies that offer limited benefits and significant side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with mild to moderate Alzheimer's disease who meet specific cognitive and health criteria.
Not a fit: Patients with severe vascular burden, significant cardiovascular diseases, or those unable to undergo surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that may slow the progression of Alzheimer's disease and improve cognitive function.
How similar studies have performed: While this approach is novel, preclinical models have shown promising results, indicating potential for success in human applications.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Singapore
- Changi General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Vincent KS Tay, MD, FAMS
- Email: vincent.tay.k.s@singhealth.com.sg
- Phone: +65 6788 8833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.