Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-22 @ 9:01 AM
Study NCT ID:
NCT06400368
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigational and Research- retinal vessel and tortuosity', 'timeFrame': 'From enrollment to the end of the treatment at 1 year.', 'description': 'Measurements of amyloid levels in the retina based on autoflourescence imaging, retinal vessel and tortuosity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retinal image', 'CAA', 'Leqembi', 'lecanamab'], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This is a proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA.', 'detailedDescription': 'Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects ages 50 and up eligible for treatment with LEQEMBI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.\n2. Male and female subjects ages ≥50 years old.\n3. Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.\n4. Patient or patient's legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.\n\nExclusion Criteria:\n\n1. History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.\n2. Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.\n3. Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,\n4. Unable or unwilling to comply with the protocol requirements."}, 'identificationModule': {'nctId': 'NCT06400368', 'briefTitle': "Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroVision Imaging'}, 'officialTitle': "Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease", 'orgStudyIdInfo': {'id': '2023.128-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dawn Lenakakis', 'role': 'CONTACT', 'email': 'dawn.lekakis@sutterhealth.org'}], 'facility': 'Sutter Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Mieko Chambers, MS', 'role': 'CONTACT', 'email': 'mchambers@neurovision.com', 'phone': '5305748449'}, {'name': 'Josef Tamory', 'role': 'CONTACT', 'email': 'jtamory@neurovision.com'}], 'overallOfficials': [{'name': 'Shawn Kile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sutter Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroVision Imaging', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}