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

This study is investigating whether a treatment called Low-Intensity Focused Ultrasound Pulsation (LIFUP) can help people with mild cognitive impairment (MCI) or mild Alzheimer's disease. LIFUP uses sound waves to target a specific part of the brain involved in memory, called the entorhinal cortex. Researchers want to see if LIFUP can increase brain activity, improve memory, and enhance how memory networks in the brain connect. You might be able to join if you are between 50 and 90 years old, speak English, and have been diagnosed with amnestic MCI or mild Alzheimer's. The study will be considered successful if LIFUP shows changes in brain activity as measured by special MRI scans.

Study design
This is an interventional study planning to enroll 144 participants. You will be randomly assigned to one of four groups, receiving different amounts of LIFUP stimulation.
What's involved
Participation involves one 1-2 hour Zoom intake session, three in-person sessions (5 hours for the first, 3 hours for the others), and three 2-hour remote Zoom follow-up sessions over about five weeks. You will complete questionnaires, memory tests, blood draws, and MRI scans with LIFUP administered inside the scanner.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured at 40 minutes after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05417555

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

Active, Not Recruiting
NAAges 50–90InterventionalTreatment
University of California, Los Angeles
~120 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Low-Intensity Focused Ultrasound Pulsation (LIFUP)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain
Measured over 40 minutes
+1 more outcome measured
Mild Cognitive Impairment
Amnestic Mild Cognitive Disorder
Deep Brain Stimulation
Mild Alzheimer's Disease
1 sites across 1 states
California1
  • Susan Y Bookheimer, PhD · PRINCIPAL_INVESTIGATOR · UCLA Psychiatry & Biobehavioral Sciences

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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
Diagnosis of one or more of the following neurological disorders: Parkinson's disease, Lou Gehrig's disease (ALS), Multiple sclerosis, Cerebral Palsy
Diagnosis of one or more of the following genetic disorders: Cystic Fibrosis, Sickle Cell Disease
Diagnosis of one or more of the following psychiatric disorders: Bipolar, Psychosis
Psychiatric illness that has not been controlled for at least two months (if controlled \>2 months, with or without medication, they are not exclusionary)
Severe lung, liver, heart, and/or kidney disease/s (e.g., heart failure, liver failure, and etc...)
Diagnosis of thyroid disorder or change of thyroid medication dose within the last 3 months
Cancer treatment/s with chemotherapy and/or radiation to head and neck, or stage 4 (metastatic) cancer
Autoimmune disorder or viral infection such as HIV, COVID 19, or hepatitis C that has caused current problems with cognition/memory
History of substance abuse in the past year
History of stroke (Transient ischemic attack / mini-stroke not exclusionary if symptoms lasted \<1 week)
History of 2 or more seizures or diagnosis of epilepsy, unless the seizures occurred prior to age 5 alongside a fever.
History of brain tumor, brain aneurysm, brain hemorrhage, or subdural hematoma (transient ischemic attack not exclusionary)
Head injury that resulted in loss of consciousness lasting \>30 minutes, cognitive issues lasting \>18 months, and/or brain abnormalities visible in CT or MRI scan
Uncontrolled high blood pressure or diabetes
Heart attack within the last year
  • Change in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain40 minutes

    Perfusion ASL fMRI data will be collected before and after sonication. Analyses will assess the statistical relationship between ASL signal throughout the brain pre and post sonication.

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

    Primary outcomes for proof of mechanism that may be depicted in the fMRI scans may include changes in BOLD-related functional connectivity increases within the DMN including regions functionally connected to the target. BOLD data will be collected before, during, and following LIFUP sonication. Analyses will assess any changes in BOLD signal in the brain following sonication.