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Ultrasonic Neuromodulation for Alzheimer's Disease

Phase 1 & 2
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild cognitive impairment or mild dementia due to Alzheimer's disease (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
Age 65-80
Must not have
Inability to complete MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months following study initiation

Summary

This trial will test a new, non-invasive brain therapy for Alzheimer's patients. MRI, PET imaging and cognitive tests will measure how well it works.

Who is the study for?
This trial is for individuals aged 65-80 with mild cognitive impairment or early-stage dementia due to Alzheimer's, confirmed by specific biomarkers. Participants must have a certain level of cognitive function (MOCA > 18) and be able to complete an MRI. Those with recent strokes, other brain diseases, or suicidal thoughts cannot join.
What is being tested?
The study tests the Diadem prototype, which uses low-intensity ultrasound waves aimed at the brain to improve cognition in Alzheimer's patients. It includes initial testing to find a safe protocol followed by a blinded comparison where some get real treatment and others don't.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing the device, headache or dizziness during or after ultrasound stimulation, and possible unknown risks associated with new non-invasive brain treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild memory problems or mild dementia due to Alzheimer's, confirmed by tests.
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I am between 65 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo an MRI scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months following study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months following study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amyloid PET
Hamilton Depression Rating Scale (HDRS-17)
Montreal Cognitive Assessment Test for Dementia (MoCA)
Secondary study objectives
Digit Span Memory Test
Hopkins Verbal Learning Test-Revised (HVLT-R)
Trail Making Test, Part A and B

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active stimulationExperimental Treatment1 Intervention
Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease.
Group II: Sham stimulationPlacebo Group1 Intervention
Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

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Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,581 Total Patients Enrolled
~27 spots leftby Apr 2027
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