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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).
This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be conducted at up to 8 sites in the United States and will enroll up to 30 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Brain Barrier (BBB) Disruption | Experimental | ExAblate Model 4000 Type 2.0 System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Brain Barrier (BBB) Disruption | Device | Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption. |
| Measure | Description | Time Frame |
|---|---|---|
| Device and procedure related adverse events | Rate of adverse events following each treatment through end of study | 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| BBB Disruption and Closure | MR images post-procedure to verify that the BBB was disrupted and subsequently closed within 24 hours. | Immediately after the end of each ExAblate treatment and 24 hours post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delray Medical Center & Florida Atlantic University | Recruiting | Delray Beach | Florida | 33484 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328855 | Derived | Mehta RI, Carpenter JS, Mehta RI, Haut MW, Wang P, Ranjan M, Najib U, D'Haese PF, Rezai AR. Ultrasound-mediated blood-brain barrier opening uncovers an intracerebral perivenous fluid network in persons with Alzheimer's disease. Fluids Barriers CNS. 2023 Jun 16;20(1):46. doi: 10.1186/s12987-023-00447-y. | |
| 36334289 | Derived |
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Subjects who meet study eligibility will undergo treatment procedures
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|
| Broward Health Medical Center & The University of Florida | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
|
| University of Florida Health Shands | Recruiting | Gainesville | Florida | 32608 | United States |
|
| Baptist Health South Florida & Florida International University | Recruiting | Miami | Florida | 33176 | United States |
|
| Advent Health | Recruiting | Orlando | Florida | 34747 | United States |
|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33612 | United States |
|
| Weill Cornell Medicine | Active, not recruiting | New York | New York | 10065 | United States |
| The Ohio State University -Wexner Medical Center | Active, not recruiting | Columbus | Ohio | 43210 | United States |
| University of Texas Southwestern Medical Center | Active, not recruiting | Dallas | Texas | 75390 | United States |
| West Virginia University Rockefeller Neuroscience Center | Active, not recruiting | Morgantown | West Virginia | 26506 | United States |
| Rezai AR, Ranjan M, Haut MW, Carpenter J, D'Haese PF, Mehta RI, Najib U, Wang P, Claassen DO, Chazen JL, Krishna V, Deib G, Zibly Z, Hodder SL, Wilhelmsen KC, Finomore V, Konrad PE, Kaplitt M; Alzheimer's Disease Neuroimaging Initiative. Focused ultrasound-mediated blood-brain barrier opening in Alzheimer's disease: long-term safety, imaging, and cognitive outcomes. J Neurosurg. 2022 Nov 4;139(1):275-283. doi: 10.3171/2022.9.JNS221565. Print 2023 Jul 1. |
| 34815790 | Derived | Mathew AS, Gorick CM, Price RJ. Multiple regression analysis of a comprehensive transcriptomic data assembly elucidates mechanically- and biochemically-driven responses to focused ultrasound blood-brain barrier disruption. Theranostics. 2021 Oct 11;11(20):9847-9858. doi: 10.7150/thno.65064. eCollection 2021. |
| 33399511 | Derived | Mehta RI, Carpenter JS, Mehta RI, Haut MW, Ranjan M, Najib U, Lockman P, Wang P, D'haese PF, Rezai AR. Blood-Brain Barrier Opening with MRI-guided Focused Ultrasound Elicits Meningeal Venous Permeability in Humans with Early Alzheimer Disease. Radiology. 2021 Mar;298(3):654-662. doi: 10.1148/radiol.2021200643. Epub 2021 Jan 5. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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