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

Launched by INSIGHTEC · Sep 12, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help treat Alzheimer's disease, specifically by using a device called the ExAblate Model 4000 Type 2.0 System. This device aims to temporarily disrupt the blood-brain barrier, which is a protective layer that can prevent medications from reaching the brain. The goal is to see if this method is safe and if it can improve treatment effectiveness for people with probable Alzheimer's.

To be eligible to participate, individuals should be between 50 and 85 years old and have a confirmed diagnosis of probable Alzheimer's disease. They should also be able to communicate any sensations they feel during the procedure. Participants will need to have been stable on any Alzheimer's medications for a certain period. However, those with certain medical conditions, like severe heart disease or a history of bleeding disorders, may not qualify. If chosen, participants can expect to undergo the ExAblate procedure and will be monitored for safety and effectiveness throughout the trial. This study is currently recruiting participants, so there is an opportunity for those eligible to contribute to important research in Alzheimer's treatment.

Gender

ALL

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