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Early U.S. REMIND surgical feasibility study enrolls three patients; investigators stress safety focus
Summary
A small U.S. early‑feasibility study of a surgical lymphatic anastomosis (REMIND) to enhance brain clearance has enrolled three patients so far with no serious adverse events; investigators have FDA early feasibility clearance to expand to 12 more patients.
Dr. Ricardo Hanel described the REMIND surgical program, an early feasibility study that connects extracranial lymphatic outflow to the venous system to augment clearance of proteins associated with dementia. He described international single‑arm series and the rationale from glymphatic research, then summarized the U.S. experience: "We enrolled the 1st 3 patients, in Jacksonville, earlier this year, at Baptist," he said, noting that two patients had moderate disease and one had mild disease and that all three went home the day after surgery with no clinical serious adverse events.
Hanel emphasized that the early U.S. study is safety‑driven and includes extensive biomarker measurement (blood, CSF, PET) and cognitive testing at baseline and follow‑ups; the FDA granted early feasibility approval to proceed with an additional 12 patients. He and colleagues are planning larger phase 2 studies and a 50‑patient European protocol; investigators urged that any broader use occur under rigorous clinical‑trial protocols to measure both safety and efficacy.
Why it matters: the trial tests a novel surgical approach based on glymphatic/lymphatic science; early safety signals are encouraging but the evidence base is preliminary and investigators stressed the need for controlled, well‑measured trials before clinical adoption.
