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ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe the ExAblate Model 4000 Type 2.0 System is and how well it works to open the blood-brain barrier, which controls what passes from the blood into the brain. It is for adults ages 50–85 who likely have Alzheimer's disease.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 50–85 years old.
  • Likely have Alzheimer's disease.
  • If taking Alzheimer's medicine, have taken it for at least 2 months and kept the same dose for at least 3 months.
  • Can describe what you feel during the ExAblate procedure, which uses ultrasound guided by MRI scans.
  • Can walk.

Who can't join

  • Have MRI findings that rule you out (not described), cannot safely have an MRI, or have a device in your body whose MRI safety is unknown or unsafe.
  • Have serious heart disease, unstable blood pressure or blood flow, or known blood vessel disease in the brain or body.
  • Have a bleeding disorder, a history of liver disease, or severely reduced kidney function.
  • Have health reasons to avoid an ultrasound contrast agent or PET scan tracer, which help with imaging, or cannot safely have a spinal tap to collect fluid around the brain and spinal cord.
  • Have serious depression with possible suicide risk, or a history of seizures or epilepsy.
  • Have untreated, uncontrolled sleep apnea (breathing pauses during sleep), long-term lung disease, or HIV.
  • Are currently in another medical research study, including one testing an experimental product or an unapproved use of a drug or device.
  • Are known to have two copies of the ApoE4 gene version.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (10)

FL

NY

OH

TX

WV