Disrupting the blood-brain barrier to treat Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of the ExAblate Model 4000 Type 2.0 System to disrupt the blood-brain barrier in patients diagnosed with probable Alzheimer's Disease. It is a prospective, multi-center, single-arm study that will involve three serial procedures targeting specific brain areas. The trial aims to enroll up to 30 patients across multiple sites in the United States, assessing both the safety of the intervention and its potential therapeutic effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Delray Medical Center & Florida Atlantic University
  Delray Beach, Florida, United States Recruiting
• Broward Health Medical Center & The University of Florida
  Fort Lauderdale, Florida, United States Recruiting
• University of Florida Health Shands
  Gainesville, Florida, United States Recruiting
• Baptist Health South Florida & Florida International University
  Miami, Florida, United States Recruiting
• Advent Health
  Orlando, Florida, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.