Clinical trial and study participants
A prospective phase 2 clinical trial was initiated at Rockefeller Neuroscience Institute, a tertiary academic neuroscience center, according to a protocol approved by the U.S. Food and Drug Administration and local institutional review board (ClinicalTrials.gov identifier, NCT03671889). This ongoing trial is sponsored by Insightec (Haifa, Israel). Informed consent was obtained from each participant at the time of trial enrollment.Eight participants (mean age 65 years; 38% female) enrolled after meeting study eligibility requirements are included in the current study cohort (Fig. Clinical trial flow diagram. Imaging findings of participants 1–3 are published previously.