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RECRUITING

NCT05417555

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

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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).

Official title: Modulation of Hippocampal Circuitry and Memory Function with Focused Ultrasound in Amnestic MCI

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2022-09-01

Completion Date

2026-07-31

Last Updated

2024-09-05

Healthy Volunteers

Conditions

Mild Cognitive Impairment Amnestic Mild Cognitive Disorder Deep Brain Stimulation Mild Alzheimer's Disease

Interventions

DEVICE

Low-Intensity Focused Ultrasound Pulsation (LIFUP)

Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)

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 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

Locations (1)

UCLA Semel Institute for Neuroscience and Behavior

Los Angeles, California, United States