RecruitingNot ApplicableNCT05417555

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

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

Sponsor

University of California, Los Angeles

Enrollment

144 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 50 YearsMax Age: 90 Years

Inclusion Criteria5

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 Criteria32

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

Interventions

DEVICELow-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)