Evaluating Deep Cervical Lymphatic Venous Anastomosis Plus Usual Care Versus Usual Care Alone for Moderate-to-Severe Alzheimers Disease in Adults Aged 50 to 80

What this Trial Is About

Alzheimers Disease AD is a common neurodegenerative disorder primarily affecting older adults. This trial investigates the safety and effectiveness of a surgical procedure called deep cervical lymphatic venous anastomosis DC-LVA combined with usual care compared to usual care alone in reducing cognitive decline measured by the Clinical Dementia Rating-Sum of Boxes CDR-SB over 12 months in patients with moderate-to-severe AD. The study also examines changes in brain amyloid beta levels using PET imaging. Participants will be randomly assigned to receive either DC-LVA plus usual care or usual care alone. The DC-LVA procedure involves connecting deep cervical lymphatic tissue to neck veins to improve lymphatic drainage, guided by fluorescence imaging. Usual care includes medications for cognitive support if already being used. After 12 months, an open-label extension allows control group participants to opt for DC-LVA, with follow-up visits every three months through month 24. During the study, participants will attend face-to-face visits at baseline, 7 days or hospital discharge, and at 3, 6, 9, and 12 months after randomization. Researchers will assess cognitive function with standardized scales and analyze biomarkers in blood, saliva, urine, cerebrospinal fluid, and brain imaging, including MRI and metabolic markers. Safety will be monitored by recording adverse events. The total active study period spans up to 24 months including the extension phase.

Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)