Study of Deep Cervical Lymph Node to Venous Bypass Surgery for Treating Mild to Moderate Alzheimers Disease in Adults Aged 50 to 80

What this Trial Is About

Alzheimers disease AD is a common cause of dementia characterized by the buildup of harmful proteins that affect brain function and lead to cognitive decline. Current treatments offer limited relief and have significant side effects. This trial explores a new surgical procedure called deep cervical lymph node to venous bypass DCLNV-BP, which aims to improve the clearance of these harmful proteins and potentially slow or improve symptoms in patients with mild to moderate AD. The study is a proof of concept designed to assess safety and preliminary effectiveness. Participants will undergo the DCLNV-BP procedure under general anesthesia. This is an open-label, single-arm study without a comparison group. The surgery targets the lymphatic drainage system of the brain to enhance removal of neurotoxic proteins. The study will also include evaluations using biomarkers and brain imaging to better understand how the treatment may work. The treatment period spans up to two years to monitor outcomes and patient response. During the trial, participants will have regular assessments including cognitive tests like the Mini-Mental State Examination, Montreal Cognitive Assessment, Clinical Dementia Rating, and others to track changes in cognition, behavior, and quality of life over two years. Additional monitoring involves brain MRI and PET scans along with fluid biomarker tests. Safety is closely tracked through adverse event reporting. Caregiver burden and daily living abilities will also be evaluated. The trial aims to provide valuable data for future studies and potential new approaches for AD care.

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