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Focused Ultrasound for Early Alzheimer's Disease (LIFUP-MCIAD Trial)
LIFUP-MCIAD Trial Summary
This trial is testing whether a new brain stimulation technique can improve memory in people with early Alzheimer's disease.
LIFUP-MCIAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLIFUP-MCIAD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LIFUP-MCIAD Trial Design
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Who is running the clinical trial?
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- My high blood pressure or diabetes is not under control.I have had a brain tumor, aneurysm, hemorrhage, or subdural hematoma.My thyroid medication dose has not changed in the last year.I am not currently receiving treatment for hepatitis, HIV, autoimmune disorders, or to prevent transplant rejection.I have had a severe head injury or concussion with significant symptoms or findings.I have 5 or more gold teeth that cannot be removed.I have been diagnosed with Cystic Fibrosis or Sickle Cell Disease.My cancer has spread to other parts of my body.I have a psychiatric disorder but it's not well-controlled anxiety or depression.I do not have severe heart, liver, lung, or kidney disease.I have received chemotherapy or radiation for head or neck cancer.I have had a stroke in the past.I am between 50 and 90 years old.I have had 2 or more seizures or have been diagnosed with epilepsy, but not due to fever before age 5.I have been diagnosed with a neurological disorder like Alzheimer's, Parkinson's, ALS, MS, or Cerebral Palsy.I weigh more than 275 pounds.I had a heart attack in the past year.I can understand and agree to the study's details.I am taking medication to help with my memory or thinking.I take prescribed medication for migraines every day.My hearing and vision are normal, or corrected to be normal.I have been diagnosed with amnestic mild cognitive impairment.
- Group 1: LIFUP Dose Group 3
- Group 2: LIFUP Dose Group 1
- Group 3: LIFUP Dose Group 2
- Group 4: Sham LIFUP
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What do researchers hope to gain from this experiment?
"This 40 minute trial has been designed to measure changes in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout the Brain. Secondary outcomes involve assessing memory through Rey Verbal Learning Test Scores, which involves recalling a list of 15 words over 5 trials and 30 minutes later as an indicator for short-term and long-term memory respectively; post-hoc biomarker analysis of plasma AB42/40 ratio as predictor of tFUS efficacy, where values lower than 0.160 suggest high risk for Alzheimer's disease; lastly, post-hoc biomarker analysis involving APOE-4 status to predict"
Is recruitment still underway for this clinical procedure?
"The information posted on clinicaltrials.gov attests to this study not currently recruiting patients, having been initially launched on September 1st 2022 and last updated 2 days later. Nonetheless, there are 602 other active trials that are looking for participants at the present moment."
Are people over 55 years old being accepted as participants in this research endeavor?
"Candidates aged 50 and above, but below 90 years old are being admitted to this clinical study."
Who is eligible to join this medical experiment?
"This research requires the recruitment of 144 individuals aged 50 to 90, all with a pre-existing Deep Brain Stimulation treatment. Additionally, these participants must be diagnosed with Amnestic Mild cognitive impairment (MCI), English speaking, right handed; and have normal hearing or vision that can be corrected as necessary. Further, they must also agree to provide informed consent through UBACC protocols put forward in 2007 by Jeste et al."
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