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

About

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 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
90 Years

Inclusion Criteria

  • 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

Exclusion Criteria

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

Join this Trial

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Study Stats
Protocol No.
21-000995
Category
Brain/Neurological Diseases
Contact
tFUS Recruitment UCLA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05417555
For detailed technical eligibility, visit ClinicalTrials.gov.