Health TrialsbyHealthPanel

Ultrasonic Debris Clearance to Promote Brain Resilience

ConditionsAlzheimer s DiseaseMCI With Increased Risk for Alzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: ActiveExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Related Adverse Events

All reported adverse events including clinically meaningful vital sign changes, laboratory test abnormalities, physical and cognitive symptoms, and new imaging abnormalities not present at baseline.

Time frame
baseline through 2 months post-treatment initiation (up to 3 months)

Secondary outcomes

1

Changes from baseline in a tablet-based cognitive assessment

Changes from baseline in tablet-based cognitive task performance (tabCAT) in the treatment condition compared to the sham

Time frame
baseline through 1 month post-treatment initiation (up to 3 months)
2

Change From Baseline in Clinical Dementia Rating - Sum of Boxes Score

The Clinical Dementia Rating - Sum of Boxes assesses cognitive and functional impairment associated with dementia. Total scores range from 0 to 18, with higher scores indicating greater impairment and a worse outcome.

Time frame
baseline, 1 month post-treatment initiation (up to 3 months)
3

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 Score

The Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 assesses cognitive impairment associated with Alzheimer's disease. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment and a worse outcome.

Time frame
baseline, 1 month post-treatment initiation (up to 3 months)
4

Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment Score

The Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment assesses functional ability in activities of daily living in individuals with mild cognitive impairment. Total scores range from 0 to 53, with higher scores indicating better functional ability and a better outcome.

Time frame
baseline, 1 month post-treatment initiation (up to 3 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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