RecruitingNot Applicable

Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

United States144 participantsStarted 2022-09-01

Plain-language summary

The goal of this study is to investigate whether Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting a part of the brain involved in memory will have an affect on brain activity and whether it may improve memory in people with Mild Cognitive Impairment and Mild Alzheimer's Disease. The main questions the study seeks to answer are: 1. Can LIFUP increase brain activity in the targeted area? 2. Can LIFUP improve memory in people with MCI and mild AD? 3. Can LIFUP improve connectivity of memory networks in the brain? Participants in this study will complete MRIs and memory testing, and receive Low Intensity Focused Ultrasound to a part of their brain involved in memory (the entorhinal cortex).

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Amnestic MCI or Mild Alzheimer's diagnosis * Age 50-90 * English-speaking * Ability to provide informed consent * Normal or corrected-to-normal hearing and vision Exclusion Criteria GENERAL * Participation in another clinical trial * Active use of immunotherapeutic medications for cognition (Aduhelm, Leqembi, Kisunla) * Moderate to Severe Alzheimer's * Inability to provide informed consent MRI-Related: * Weight exceeding 275 pounds * Pregnancy, suspicion of pregnancy, or attempting to become pregnant * Claustrophobia * Difficulties during previous MRIs * Top permanent retainer (bottom only is okay), 5 or more non-removable gold-teeth, metal braces, top spacers, and/or palate expanders * Any of the following implants: Cardiac Pacemaker, Aneurysm clips, Cochlear implants, Defibrillator, Electrodes or wires, Magnetically-activated device, Spinal cord stimulator, Infusion or insulin pumps, Implanted drug infusion device, Deep brain stimulation device * Non-removable hairpieces, hairpiece extensions, and/or piercings * Facial tattoos or permanent makeup * Metal implants that are MR-incompatible, or where participant is unable to provide sufficient information to determine MR compatibility * Previous injury by metallic foreign body (e.g., bullet, BB, shrapnel) where the object entered the body and participant lacks doctor's confirmation that it was fully removed Medical: * Diagnosis of one or more of the following neurological disorders: Parkinson's dis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain

Timeframe: 40 minutes

Changes in BOLD-related functional connectivity from baseline in fMRI brain scan to 40 minutes.

Timeframe: 40 minutes

Trial details

NCT IDNCT05417555

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Natalie Rotstein

‭(310) 794-0077‬ tfus@mednet.ucla.edu

View on ClinicalTrials.gov More Mild Cognitive Impairment trials