Using focused ultrasound to improve memory in mild cognitive impairment and mild Alzheimer's disease
Modulation of Hippocampal Circuitry and Memory Function With Focused Ultrasound in Amnestic MCI
This study is testing if a new ultrasound treatment can help improve memory in people with mild cognitive impairment and mild Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05417555 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Low Intensity Focused Ultrasound Pulsation (LIFUP) on brain activity and memory improvement in individuals with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease. Participants will undergo MRI scans and memory testing, followed by LIFUP treatment targeting the entorhinal cortex, a brain region associated with memory. The study will randomly assign participants to different groups to assess varying doses of LIFUP stimulation. The aim is to determine if LIFUP can enhance brain connectivity and improve memory function over the course of five weeks.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-90 diagnosed with amnestic Mild Cognitive Impairment or Mild Alzheimer's Disease who can provide informed consent.
Not a fit: Patients with moderate to severe Alzheimer's disease or those currently participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new non-invasive treatments for improving memory in patients with cognitive impairments.
How similar studies have performed: While focused ultrasound is a novel approach in this context, similar studies have shown promise in other neurological applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- UCLA Semel Institute for Neuroscience and Behavior — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan Y Bookheimer, PhD — UCLA Psychiatry & Biobehavioral Sciences
- Study coordinator: Natalie Rotstein
- Email: tfus@mednet.ucla.edu
- Phone: (310) 794-0077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.