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Low-Intensity Focused Ultrasound (LIFU) for Mild Cognitive Impairment due to Alzheimer's Disease

This study is testing a device called low-intensity focused ultrasound (LIFU) neuromodulation for people with mild cognitive impairment (MCI) due to Alzheimer's disease. LIFU uses sound waves to target a specific area of the brain. The main goal is to see if LIFU is safe and well-tolerated. Researchers will also look at any changes in your thinking and memory. You might be able to join if you are 45-85 years old, have MCI due to Alzheimer's, and can communicate during the procedure. The study plans to enroll 15 participants. The current recruitment status is unclear.

Study design
This is an early study involving 15 participants, where everyone receives the LIFU treatment. It is a single-center study.
What's involved
You will undergo a single LIFU procedure. Your safety and cognitive changes will be measured at the start and 7 days after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 7 days after the procedure to check for side effects and cognitive changes.

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NCT05997030

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Recruiting
NAAges 45–85InterventionalTreatment
Ali Rezai
~15 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:low intensity focused ultrasound (LIFU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Treatment Emergent Adverse Events
Measured over baseline and 7 and days after study procedure
+1 more outcome measured

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Ali Rezai, MD · PRINCIPAL_INVESTIGATOR · WVU Rockefeller Neuroscience Institute

Who to contact

Marc Haut, PhD
[email protected]
3042936276
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males and non-pregnant females, aged 45-85 years
Able and willing to give informed consent
Must meet the clinical criteria for MCI due to Alzheimer's disease
If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
Able to communicate sensations during the LIFU procedure

Exclusion

Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
Participants with a history of seizure disorder.
Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
Participant does not speak English
Participant is pregnant or planning to be pregnant

What this trial measures

  • Occurrence of Treatment Emergent Adverse Eventsbaseline and 7 and days after study procedure

    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

  • Cognitive Changebaseline and 7 days after procedure

    Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)