NCT06965062: CLyVeB-AD-1

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

Recruiting now NA Last updated 13 January 2026

What this trial tests

NA trial testing Deep cervical lymph node to venous bypass (DCLNV-BP) in Alzheimer Disease in 10 participants. Currently enrolling.

Timeline

1 April 2025

Primary endpoint
31 March 2028

31 March 2030

Quick facts

Lead sponsor	Vincent Tay Khwee Soon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 April 2025
Primary completion	31 March 2028
Estimated completion	31 March 2030
Sites	1 location across Singapore

Drugs / interventions tested

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

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia Alzheimer Type — all drugs for Dementia Alzheimer Type →
• Dementia Alzheimer's Type — all drugs for Dementia Alzheimer's Type →
• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Vincent Tay Khwee Soon

Who can join

Adults 50 to 80, any sex, with Alzheimer Disease or Dementia Alzheimer Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 pioneered the deep cervical lymph node to venous bypass (DCLNV-BP) procedure with very promising early outcomes. The observed improvement had been attributed to enhanced clearance of the neurotoxic proteins. Knowledge gap and clinical equipoise remain, and clinical trials are required to understand the safety, mechanism of action, patient selection, and long-term outcomes.

In this proof of concept study, the investigators aim to assess safety and preliminary efficacy of DCLNV-BP in AD. An approach using objective clinical assessments, biomarkers and neuroimaging, to assess safety, evaluate preliminary efficacy and elucidate the possible mechanism underlying the observed effects, is undertaken. Since there are limited effective treatment for AD, this procedure is potentially ground breaking if it proves to halt progression or even improve patients' cognition, function and behaviour. Indirectly, this will have enormous health economic benefit for Singapore and the developed world that is facing the silver tsunami. Findings from this pilot study will lay the groundwork for future trials and research collaboration in AD and other neurodegenerative diseases.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.