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New treatment option for Mild Cognitive Impairment
Official title Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
ClinicalTrials.gov ID: NCT05417555
What this study is testing
- What it's testing
- 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: 1.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.