Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 6:14 AM
Study NCT ID:
NCT03739905
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device and procedure related adverse events', 'timeFrame': '6 months', 'description': 'Rate of adverse events following each treatment through end of study'}], 'secondaryOutcomes': [{'measure': 'BBB Disruption and Closure', 'timeFrame': 'Immediately after the end of each ExAblate treatment and 24 hours after each treatment', 'description': 'MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed'}, {'measure': "Change in Alzheimer's Disease Assessment Scale-Cognition", 'timeFrame': 'Baseline and 6 months', 'description': 'Mental cognition assessment'}, {'measure': 'Change in Amyloid Tracer uptake', 'timeFrame': 'Baseline and Day 8 following the third treatment', 'description': 'PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance guided Focal Ultrasound (MRgFUS)', "Alzheimer's Disease", 'ExAblate', 'Blood Brain Barrier'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '36694943', 'type': 'DERIVED', 'citation': "Meng Y, Goubran M, Rabin JS, McSweeney M, Ottoy J, Pople CB, Huang Y, Storace A, Ozzoude M, Bethune A, Lam B, Swardfager W, Heyn C, Abrahao A, Davidson B, Hamani C, Aubert I, Zetterberg H, Ashton NJ, Karikari TK, Blennow K, Black SE, Hynynen K, Lipsman N. Blood-brain barrier opening of the default mode network in Alzheimer's disease with magnetic resonance-guided focused ultrasound. Brain. 2023 Mar 1;146(3):865-872. doi: 10.1093/brain/awac459."}, {'pmid': '34815790', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33693781', 'type': 'DERIVED', 'citation': 'Meng Y, Pople CB, Suppiah S, Llinas M, Huang Y, Sahgal A, Perry J, Keith J, Davidson B, Hamani C, Amemiya Y, Seth A, Leong H, Heyn CC, Aubert I, Hynynen K, Lipsman N. MR-guided focused ultrasound liquid biopsy enriches circulating biomarkers in patients with brain tumors. Neuro Oncol. 2021 Oct 1;23(10):1789-1797. doi: 10.1093/neuonc/noab057.'}]}, 'descriptionModule': {'briefSummary': "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 open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).", 'detailedDescription': "This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model 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 a single center in Canada and will enroll up to 30 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or Female between 50-85 years of age\n2. Probable Alzheimer's Disease (AD)\n3. 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\n4. Able to communicate sensations during the ExAblate MRgFUS procedure\n5. Ambulatory\n\nExclusion Criteria:\n\n1. MRI Findings\n2. Presence of unknown or MR unsafe devices anywhere in the body\n3. Significant cardiac disease or unstable hemodynamic status\n4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer\n5. History of a bleeding disorder\n6. History of liver disease\n7. Known cerebral or systemic vasculopathy\n8. Significant depression and at potential risk of suicide\n9. Any contraindications to MRI scanning\n10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid\n11. Untreated, uncontrolled sleep apnea\n12. History of seizure disorder or epilepsy\n13. Severely Impaired renal function\n14. 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\n15. Chronic pulmonary disorders\n16. Positive human immunodeficiency virus (HIV)\n17. Known apolipoprotein E allele (ApoE4) homozygosity"}, 'identificationModule': {'nctId': 'NCT03739905', 'briefTitle': "ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'InSightec'}, 'officialTitle': "A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-Guided Focused Ultrasound in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AL003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Brain Barrier (BBB) Disruption', 'description': 'The ExAblate Model 4000 Type 2.0 System', 'interventionNames': ['Device: Blood Brain Barrier (BBB) Disruption']}], 'interventions': [{'name': 'Blood Brain Barrier (BBB) Disruption', 'type': 'DEVICE', 'otherNames': ['ExAblate Neuro'], 'description': 'Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.', 'armGroupLabels': ['Blood Brain Barrier (BBB) Disruption']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Allison Bethune', 'role': 'CONTACT', 'email': 'allison.bethune@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '4831'}, {'name': 'Nir Lipsman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Neurosurgery, Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InSightec', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Focused Ultrasound Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}