No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
50 (estimated)
Sponsor
InSightec · Industry
Who this trial is looking for
This trial is looking for adults with probable Alzheimer's Disease. If you join, you will undergo a procedure using the ExAblate system to disrupt the blood-brain barrier and help evaluate its safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outHIVChronic pulmonary disordersKnown apolipoprotein E allele (ApoE4) homozygosity
You may be able to join if
I am between 50 and 85 years old
I have probable Alzheimer's Disease
I can communicate during the procedure
I am able to walk independently
I have been taking my Alzheimer's medication for at least 2 months
I have been on a stable dose of my Alzheimer's medication for at least 3 months
You may not be able to join if
I have significant heart disease
I have a history of seizures or epilepsy
I have untreated, uncontrolled sleep apnea
I have a history of liver disease
I have major depression and may be at risk of suicide
I have a bleeding disorder
I have significant problems with my kidneys
I have known serious blood vessel problems in my brain or body
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Male or Female between 50-85 years of age
2. Probable Alzheimer's Disease (AD)
3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
4. Able to communicate sensations during the ExAblate MRgFU…
Inclusion Criteria:
1. Male or Female between 50-85 years of age
2. Probable Alzheimer's Disease (AD)
3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
4. Able to communicate sensations during the ExAblate MRgFUS procedure
5. Ambulatory
Exclusion Criteria:
1. MRI Findings
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Significant cardiac disease or unstable hemodynamic status
4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer
5. History of a bleeding disorder
6. History of liver disease
7. Known cerebral or systemic vasculopathy
8. Significant depression and at potential risk of suicide
9. Any contraindications to MRI scanning
10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid
11. Untreated, uncontrolled sleep apnea
12. History of seizure disorder or epilepsy
13. Severely Impaired renal function
14. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
15. Chronic pulmonary disorders
16. Positive human immunodeficiency virus (HIV)
17. Known apolipoprotein E allele (ApoE4) homozygosity
Contacts
No contact information available.
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