Ultrasonic Debris Clearance to Promote Brain Resilience
NCT07573982 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-05-07
Summary
This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity focused ultrasound intervention, in amyloid-positive adults who are asymptomatic but at risk for Alzheimer's disease, or who have mild cognitive impairment or mild dementia. The study is designed to test whether repeated UDC sessions can be delivered safely and feasibly in this population, while also exploring efficacy via biomarkers and clinical measures.
Conditions
- Alzheimer s Disease
- MCI With Increased Risk for Alzheimer Disease
Interventions
- DEVICE
-
Ultrasonic Debris Clearance
Ultrasonic debris clearance (UDC) delivered with a 250-kHz low-intensity transcranial ultrasound device for approximately 30 minutes per session across 8 sessions over 4 weeks. The intervention is designed to provide broad transcranial ultrasound exposure to promote glymphatic clearance, with real-time monitoring of transmitted power and matched study procedures including EEG, MRI, blood, and clinical assessments.
- DEVICE
-
sham
Sham procedure matched to the active UDC intervention in schedule, session duration, device setup, and study procedures, but without transcranial ultrasound energy delivery while maintaining participant blinding.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Raag Airan, MD, PhD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- United States
Study Locations
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