Transcranial blood-brain barrier opening in Alzheimer's disease patients using a portable focused ultrasound system with real-time 2-D cavitation mapping
Summary
This phase 1 clinical study investigated a portable, non-invasive neuronavigation-guided FUS system with real-time 2-D microbubble cavitation mapping in 6 mild-to-moderate AD patients. BBB opening was achieved in 5 of 6 subjects with an average volume of 983 mm3. Cavitation dose significantly correlated with opening volume, and larger opening volumes correlated with increased AD biomarker levels in serum-derived extracellular vesicles.
Why it matters
This study demonstrates the first portable FUS system for BBB opening that does not require MRI suite integration, potentially enabling widespread clinical adoption. The real-time cavitation mapping and correlation with biomarker changes validate the system's precision and biological effect, bringing point-of-care BBB opening closer to reality for AD treatment.
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