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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or Female between 50-85 years of age
Diagnosed with probable Alzheimer's Disease (AD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new tool to open the blood-brain barrier in patients with Alzheimer's Disease in order to see if it is safe and effective.
Who is the study for?
This trial is for men and women aged 50-85 with probable Alzheimer's Disease, who can communicate during the procedure and are able to walk. They must have been on stable Alzheimer's medication for at least 3 months if applicable. Excluded are those with liver disease, severe depression, MRI contraindications, significant heart issues, other ongoing clinical trials participation, bleeding disorders, vasculopathy, untreated sleep apnea or seizures.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the ExAblate® Model 4000 Type 2.0 system in opening the blood-brain barrier (BBB) in patients with Alzheimer's Disease. The goal is to see if this non-invasive technique can help treat AD by allowing medications better access to the brain.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally BBB disruption could potentially lead to temporary discomfort or sensations during treatment; there may also be risks associated with exposure to magnetic fields or ultrasound contrast agents used in the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 85 years old.
Select...
I have been diagnosed with probable Alzheimer's Disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device and procedure related adverse events
Secondary outcome measures
BBB Disruption and Closure
Change in Alzheimer's Disease Assessment Scale-Cognition
Change in Amyloid Tracer uptake
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blood Brain Barrier (BBB) DisruptionExperimental Treatment1 Intervention
The ExAblate Model 4000 Type 2.0 System
Find a Location
Who is running the clinical trial?
Focused Ultrasound FoundationOTHER
15 Previous Clinical Trials
284 Total Patients Enrolled
InSightecLead Sponsor
89 Previous Clinical Trials
3,684 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 85 years old.I have a history of liver disease.I do not have serious heart disease or unstable blood pressure and heart rate.I have a history of seizures or epilepsy.I can walk on my own without help.You have HIV.I cannot have a lumbar puncture due to health reasons.I have a long-term lung condition.I have a history of bleeding problems.I have a known blood vessel disorder in my brain or body.I have sleep apnea that hasn't been treated or controlled.My kidneys do not work well.I have two copies of the ApoE4 gene.You have serious depression and may be at risk of hurting yourself.You should not have any reasons that make it unsafe for you to have an MRI scan.You have a medical device in your body that could be unsafe during an MRI scan.I have been on a stable dose of Alzheimer's medication for at least 3 months.I cannot have certain imaging agents due to health risks.I have been diagnosed with probable Alzheimer's Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Blood Brain Barrier (BBB) Disruption
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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