Ultrasonic Debris Clearance to Promote Brain Resilience

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07573982
Status
Not Yet Recruiting

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Conditions

  • Alzheimer s Disease
  • MCI With Increased Risk for Alzheimer Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasonic Debris Clearance — DEVICE
    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.
  • sham — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Active
    Participants will receive the UDC ultrasound protocol applied to their head for multiple sessions across one month.
  • Sham Comparator: Sham
    Participants will receive a sham version of the UDC ultrasound protocol applied to their head for multiple sessions across one month.

Primary Outcome Measure

Number of Participants with Treatment-Related Adverse Events [ Time Frame: baseline through 2 months post-treatment initiation (up to 3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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