NCT05417555 · RECRUITING
Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
This trial tests whether Low-Intensity Focused Ultrasound Pulsation (LIFUP) — a non-invasive device that delivers gentle sound waves to a specific brain region — can boost memory-related brain activity in people with Mild Cognitive Impairment or mild Alzheimer's disease. Researchers will measure brain activity, memory test scores, and network connectivity using MRI. This is a Phase NA (feasibility or pilot) study, meaning the goal is to see whether the approach shows enough promise to study further. It is not a proven treatment.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-09-05