Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-19 @ 4:17 AM
Study NCT ID:
NCT03373604
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2017-12-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging Tau in Alzheimer's Disease and Normal Aging
Sponsor:
Organization:
Raw JSON
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'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '18F-MK-6240 Binding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Cognitive Impairment', 'description': 'Healthy participants without cognitive impairment'}, {'id': 'OG001', 'title': 'Cognitive Impairment', 'description': "Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia"}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Standardized uptake value ratio (SUVr)', 'unitOfMeasure': 'SUVr', 'dispersionType': 'Standard Deviation', 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{'value': '7', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 271580, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-27T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2017-12-11', 'resultsFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-23', 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-MK-6240 Binding', 'timeFrame': '1 day', 'description': 'Standardized uptake value ratio (SUVr)'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.', 'timeFrame': 'One year follow-up', 'description': 'Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-MK-6240', 'Cognitive Impairment', "Alzheimer's"], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '33646153', 'type': 'DERIVED', 'citation': "Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149."}]}, 'descriptionModule': {'briefSummary': "This study is being done to learn about tau tangles in Alzheimer's disease. A type of positron emission tomography (PET) scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.", 'detailedDescription': "This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with and without Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-MK-6240 is injected into the body. 18F-MK-6240 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 50 and older.\n2. Meet criteria for either\n\n 1. amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or\n 2. have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.\n3. Subjects unable to provide informed consent must have a surrogate decision maker.\n4. Written and oral fluency in English or Spanish.\n5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.\n6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.\n\nExclusion Criteria:\n\n1. Past or present history of certain brain disorders other than MCI or AD.\n2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.\n3. Contraindication to magnetic resonance imaging (MRI) scanning.\n4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).\n5. History of kidney disease or presence of impaired kidney function based on laboratory tests at screening visit.\n6. History of liver disease or presence of impaired liver function based on laboratory tests at screening visit.\n7. Participation in the last year in a clinical trial for a disease modifying drug for AD.\n8. Inability to have a catheter in subject's vein for the injection of radioligand.\n9. Inability to have blood drawn from subject's veins."}, 'identificationModule': {'nctId': 'NCT03373604', 'briefTitle': "Imaging Tau in Alzheimer's Disease and Normal Aging", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Imaging Tau in Alzheimer's Disease and Normal Aging With 18F-MK-6240", 'orgStudyIdInfo': {'id': 'AAAR4352'}, 'secondaryIdInfos': [{'id': 'K23AG052633-02', 'link': 'https://reporter.nih.gov/quickSearch/K23AG052633-02', 'type': 'NIH'}, {'id': '2R56AG034189-06A1', 'link': 'https://reporter.nih.gov/quickSearch/2R56AG034189-06A1', 'type': 'NIH'}, {'id': 'K24AG045334', 'link': 'https://reporter.nih.gov/quickSearch/K24AG045334', 'type': 'NIH'}, {'id': 'R01AG055299', 'link': 'https://reporter.nih.gov/quickSearch/R01AG055299', 'type': 'NIH'}, {'id': 'R01AG050440-02S1', 'link': 'https://reporter.nih.gov/quickSearch/R01AG050440-02S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive impairment', 'description': "Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)", 'interventionNames': ['Drug: 18F-MK-6240', 'Procedure: Lumbar Puncture (optional)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No cognitive impairment', 'description': 'Healthy controls', 'interventionNames': ['Drug: 18F-MK-6240', 'Procedure: Lumbar Puncture (optional)']}], 'interventions': [{'name': '18F-MK-6240', 'type': 'DRUG', 'otherNames': ['[18F]-MK6240'], 'description': "18F-MK-6240 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.", 'armGroupLabels': ['Cognitive impairment', 'No cognitive impairment']}, {'name': 'Lumbar Puncture (optional)', 'type': 'PROCEDURE', 'description': "Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.", 'armGroupLabels': ['Cognitive impairment', 'No cognitive impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Patrick Lao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Lao', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurological Sciences', 'investigatorFullName': 'Patrick Lao', 'investigatorAffiliation': 'Columbia University'}}}}