Can sound waves soothe Dementia's emotional turmoil?
NCT ID NCT07718906
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This early study tests whether a single session of focused ultrasound—using sound waves to gently stimulate a specific brain region—can safely reduce emotional symptoms like agitation, irritability, and anxiety in people with mild dementia. Fifteen participants aged 45 to 80 with Alzheimer's, frontotemporal dementia, or Lewy body dementia will receive the treatment and be monitored for side effects and changes in behavior. The goal is to see if this non-invasive approach is safe enough to study further as a potential alternative to medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a single session of focused ultrasound neuromodulation to a target brain region
- What this could lead to
- If safe and effective, this could point toward a non-invasive, drug-free way to manage emotional symptoms like agitation and anxiety in dementia.
- What could go wrong
- This is a very early feasibility study with only 15 participants. It is designed primarily to test safety, not effectiveness, and may not lead to a reliable treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Age 45-80 years at time of enrollment. * Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria. * Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition * Able to undergo MRI scanning * Adequate auditory and visual abilities to complete study procedures as determined by the investigator. * Availability of a study partner (legally authorized representative, caregiver, or family member) who has regular contact with the participant and can provide collateral information and assist with assessments. * Ability to provide informed consent, or assent with legally authorized representative (LAR) consent in accordance with WVU IRB policy and applicable West Virginia law. .Currently under the care of a licensed physician, psychiatrist, or neurologist, and agrees to allow communication between investigators/study staff and healthcare providers for purposes of eligibility confirmation and safety monitoring. EXCLUSION CRITERIA * Moderate to severe dementia (i.e., beyond mild stage). * Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments. * History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk. * Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood/anxiety disorder requiring immediate intervention. * Elevated suicide risk with History of medically verified suicide attempt within the past year. * Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician. * Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening. * Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505, United States
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