Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
a study on Mild Cognitive Impairment Amnestic Mild Cognitive Disorder Deep Brain Stimulation Alzheimer's Disease Neurocognitive Disorder
Summary
- Eligibility
- for people ages 50-90 (full criteria)
- Location
- at Los Angeles, California
- Dates
- study startedcompletion around
- Principal Investigator
- by Susan Y Bookheimer, PhDTaylor P Kuhn, PhD
Description
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:
- Can LIFUP increase brain activity in the targeted area?
- Can LIFUP improve memory in people with MCI and mild AD?
- 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
Details
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 study will entail one Zoom intake session, three in-person sessions and three remote Zoom follow-up sessions over the course of about five weeks. The in-person sessions will take about 5 hours for the first and 3 hours for the following two. The Zoom intake session will take 1-2 hours, and the Zoom follow-up sessions will take about 2 hours each. Participants will be asked to complete questionnaires and tests of learning and memory, have their blood drawn, undergo painless ultrasound stimulation to a part of their brain related to memory, and complete MRI scans of their brain. LIFUP will be administered inside of the MRI scanner, so that we can measure changes in brain activity in real-time.
At the start of the study, you will be randomly assigned to one of four different groups that determines the amount of LIFUP stimulation you will receive. You have an equal chance of being assigned to each group. Participants in one of the three active stimulation groups will receive either 1 dose, 2 doses, or 3 doses of LIFUP at their second in-person session, and will receive the same dose again at their third in-person session. Participants in the placebo group will receive no LIFUP stimulation at either MRI/LIFUP session (in-person visits 2 and 3). However, if at the end of our study, the treatment has been shown to be effective, and you were a placebo subject, we will offer you a free session using the most effective dose.
Keywords
Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder, Deep Brain Stimulation, Mild Alzheimer's Disease, deep brain stimulation (DBS), transcranial focused ultrasound stimulation (tFUS), memory, low-intensity focused ultrasound pulsation (LIFUP), fMRI, mci, noninvasive brain stimulation (NIBS), ultrasound, Alzheimer's Disease, Mild Alzheimer's, Alzheimer Disease, Cognitive Dysfunction, Cognition Disorders
Eligibility
You can join if…
Open to people ages 50-90
- Amnestic MCI or Mild Alzheimer's diagnosis
- Age 50-90
- English-speaking
- Right-handed
- Ability to provide informed consent
- Normal or corrected-to-normal hearing and vision
You CAN'T join if...
GENERAL
- Participation in another clinical trial
- Active use of immunotherapeutic medications for cognition (Aduhelm)
- 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 one year (if controlled >1 year, 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 year
- 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
Location
- UCLA Semel Institute for Neuroscience and Behavior
accepting new patients
Los Angeles California 90024 United States
Lead Scientists at UCLA
- Susan Y Bookheimer, PhD
Dr. Susan Y. Bookheimer holds the Joaquin M. Fuster Chair in Cognitive Neuroscience. - Taylor P Kuhn, PhD
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, Los Angeles
- Links
- Study Website
- ID
- NCT05417555
- Study Type
- Interventional
- Participants
- Expecting 144 study participants
- Last Updated