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Device

BBB Opening for Alzheimer's Disease

N/A
Recruiting
Research Sponsored by InSightec
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)
Must not have
History of liver disease
Significant cardiac disease or unstable hemodynamic status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am between 50 and 85 years old.
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I have been diagnosed with probable Alzheimer's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of liver disease.
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I do not have serious heart disease or unstable blood pressure and heart rate.
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I have a history of seizures or epilepsy.
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I cannot have a lumbar puncture due to health reasons.
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I have a long-term lung condition.
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I have a history of bleeding problems.
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I have a known blood vessel disorder in my brain or body.
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I have sleep apnea that hasn't been treated or controlled.
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My kidneys do not work well.
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I have two copies of the ApoE4 gene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device and procedure related adverse events
Secondary study objectives
BBB Disruption and Closure
Change in Alzheimer's Disease Assessment Scale-Cognition
Change in Amyloid Tracer uptake

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
17 Previous Clinical Trials
430 Total Patients Enrolled
InSightecLead Sponsor
91 Previous Clinical Trials
3,768 Total Patients Enrolled

Media Library

ExAblate® Model 4000 Type 2.0 system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03739905 — N/A
Alzheimer's Disease Research Study Groups: Blood Brain Barrier (BBB) Disruption
Alzheimer's Disease Clinical Trial 2023: ExAblate® Model 4000 Type 2.0 system Highlights & Side Effects. Trial Name: NCT03739905 — N/A
ExAblate® Model 4000 Type 2.0 system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739905 — N/A
~4 spots leftby Dec 2025
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