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No phaseRecruitingAge-related condition

Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease (NMSBBBOYUSH01)

A Single-center, Single-arm, Prospective, Open-label, Pilot Clinical Trial to Evaluate the Safety and Efficacy of the Focused Ultrasound Stimulator System (NMS-01) for Transient Blood-Brain Barrier (BBB) Opening in Patients With Mild to Moderate Alzheimer's Disease

Sponsor
Neumous Inc. (Industry)
Enrolment
10 planned
Conditions
Alzheimer's Disease; Blood Brain Barrier
Interventions
NMS-01
Ages
adults, older adults
Registry
NCT07869238

Full record on ClinicalTrials.gov

From the registry

A single-center, single-arm, prospective, open-label, pilot clinical trial to evaluate the safety and efficacy of the Focused ultrasound stimulator system (NMS-01) for transient Blood-Brain Barrier (BBB) opening in patients with mild to moderate Alzheimer's disease

Primary outcomes

  • Proportion of subjects with successful BBB opening (%)
  • Proportion of successful BBB opening relative to the number of targets within the application site(%)
  • Accuracy of BBB opening location relative to the pre-targeting location(%)
  • BBB recovery or not at 24 hours (±6 hours) or 7 days(%)

History

  1. Study completion expected

  2. Primary completion expected

  3. Registered

  4. Started