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ExAblate BBB Disruption for Alzheimer's Disease
Study Summary
This trial is testing a new tool to see if it can help patients with Alzheimer's by disrupting the blood-brain barrier.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I cannot have a lumbar puncture due to health reasons.My kidney function is severely impaired.I am between 50 and 85 years old.I have been diagnosed with probable Alzheimer's Disease.You can tell the doctor how you are feeling during the procedure.I can walk on my own without help.I have been diagnosed with probable Alzheimer's Disease.I cannot have certain imaging agents due to health risks.I can walk on my own without help.I do not have serious heart problems or unstable blood pressure.I have sleep apnea that hasn't been treated or controlled.I have been on a stable dose of my Alzheimer's medication for at least 3 months.I have been diagnosed with probable Alzheimer's Disease.You can tell the doctor how you are feeling during the ExAblate MRgFUS procedure.I am between 50 and 85 years old.You can tell the doctor if you feel anything during the procedure.I've been on a stable dose of Alzheimer's medication for at least 3 months.I have a history of seizures or epilepsy.I have a history of bleeding problems.Results from an MRI scan.I have a history of liver disease.You have any medical devices in your body that could be unsafe for an MRI.I have a diagnosed blood vessel disorder in my brain or body.You have tested positive for HIV.I am experiencing severe depression and may be at risk of harming myself.I have a long-term lung condition.I have two copies of the ApoE4 gene.
- Group 1: Blood Brain Barrier (BBB) Disruption
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants has this research recruited thus far?
"This research project requires 30 qualified participants. Those eligible to take part can do so from various authorised sites, such as Broward Health Medical Center in Fort Lauderdale, Texas and Baptist Health South Florida in Miami, New york."
Are there any openings left for participants in this research project?
"Affirmative, the clinicaltrials.gov portal reflects that this trial is recruiting participants; it was initially posted on September 28th 2018 and recently revised on July 11th 2022. The study seeks to enrol 30 patients at 9 different sites."
Are participants of advanced age eligible for this research study?
"The parameters for this evaluation stipulate that only those aged 50-85 can be admitted."
What is the extent of geographical participation for this research endeavor?
"Nine medical centres are currently participating in this investigation, including Broward Health Medical Center in Fort Lauderdale and Baptist Health South Florida in Miami. Additionally, University of Texas Southwestern Medical Center located Dallas is also included among the 9 study sites."
What is the criteria for enrollment in this clinical experiment?
"This research is looking for 30 individuals with Alzheimer's disease, aged between 50 and 85. To be eligible applicants must demonstrate the capacity to communicate during the ExAblate MRgFUS process, have been on a stable dosage of their prescribed medication for at least two months (if applicable), identify as male or female, display symptoms consistent with probable AD, and possess basic ambulatory skills."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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Why did patients apply to this trial?
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