Status:
RECRUITING
Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Amnestic Mild Cognitive Disorder
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief 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 i...
Detailed Description
This is a proof of concept trial of Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting the entorhinal cortex in patients with amnestic MCI and Mild Alzheimer's Disease. Participation in the ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05417555
Start Date
September 1 2022
End Date
July 31 2026
Last Update
September 5 2024
Active Locations (1)
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1
UCLA Semel Institute for Neuroscience and Behavior
Los Angeles, California, United States, 90024