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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
15
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 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.
Stanford University
Stanford, California, United States
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)
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)
Changes from baseline in the CDR-SB
Changes from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) in the treatment condition compared to the sham
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Changes from baseline in the ADASCog13 measure of cognition.
Changes from baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADASCog13) in the treatment condition compared to the sham
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Changes from baseline in the ADCS-MCI-ADL
Changes from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment (ADCS-MCI-ADL) in the treatment condition compared to the sham
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Changes from baseline in the Mini-Mental State Examination (MMSE)
Changes from baseline in the Mini-Mental State Examination (MMSE) in the treatment condition compared to the sham
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Time frame: baseline, 1 month post-treatment initiation (up to 3 months)