Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02103894
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2014-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000070627', 'term': 'Chronic Traumatic Encephalopathy'}, {'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}, {'id': 'D020774', 'term': 'Pick Disease of the Brain'}, {'id': 'D024801', 'term': 'Tauopathies'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D020208', 'term': 'Brain Injury, Chronic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}, {'id': 'C545186', 'term': 'florbetapir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain uptake of [18F]T807 ([18F]MNI-777)', 'timeFrame': '2 years', 'description': "To quantitatively assess the brain uptake of \\[18F\\]MNI-777 (\\[18F\\]T807), an imaging biomarker for tau pathology in brain, using positron emission tomography (PET) in individuals with clinically diagnosed tauopathies including: Alzheimer's disease (AD), Parkinson's disease (PD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and frontal temporal dementia/Pick's disease (FTD) and healthy controls (HC)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease (AD)", "Parkinson's disease (PD)", 'Progressive supranuclear palsy (PSP)', 'Chronic traumatic encephalopathy (CTE)', 'Frontal temporal dementia (FTD)', "Pick's disease", 'tauopathies'], 'conditions': ["Alzheimer's Disease (AD)", "Parkinson's Disease (PD)", 'Chronic Traumatic Encephalopathy (CTE)', 'Progressive Supranuclear Palsy (PSP)', 'Frontal Temporal Dementia (FTD)', "Pick's Disease", 'Tauopathies']}, 'referencesModule': {'references': [{'pmid': '23478462', 'type': 'BACKGROUND', 'citation': 'Jordan BD. The clinical spectrum of sport-related traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):222-30. doi: 10.1038/nrneurol.2013.33. Epub 2013 Mar 12.'}, {'pmid': '6610841', 'type': 'BACKGROUND', 'citation': "McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939."}, {'pmid': '8710059', 'type': 'BACKGROUND', 'citation': 'Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.'}], 'seeAlsoLinks': [{'url': 'http://www.mnimaging.com', 'label': 'Molecular NeuroImaging'}, {'url': 'http://www.indd.org', 'label': 'Institute for Neurodegenerative Disorders'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to assess \\[18F\\]MNI-777 PET imaging as a tool to detect tau pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy, including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age- and gender-matched healthy subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor all subjects:\n\n* Written informed consent or assent is obtained.\n* Willing and able to cooperate with study procedures.\n* For females, non-child bearing potential or negative urine pregnancy test on day of \\[18F\\]MNI-777 injection.\n\nAlzheimer Disease subjects:\n\n* The participant is 50 years or older.\n* Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria (McKann, 1984)\n* Modified Hachinski Ischemia Scale score of ≤ 4.\n\nParkinson's Disease subjects:\n\n* The participant is 30 years or older.\n* Participants have a clinical diagnosis of PD based on the UK Brain Bank Criteria (Hughes, et al., 1982).\n* The duration of diagnosis of PD is \\<20 years prior to the imaging visit\n* PD subjects must be on stable doses of medications for a period of at least 30 days prior to the imaging visit.\n* Treatment with dopamine replacement therapies or other symptomatic therapies for PD is permitted; however, subjects must be on a stable dose of medications 30 days prior to the imaging visit.\n\nProgressive Supranuclear Palsy subjects:\n\n* The participant is 30 years or older.\n* Participants have a clinical diagnosis of PSP based on National Institute of Neurological Disorders and Stroke/ (NINDS) and the Society for PSP (SPSP) criteria (Litvan, et al. 1996).\n\nChronic Traumatic Encephalopathy subjects:\n\n* The participant is 18 years or older.\n* Subjects with a diagnosis of probable CTE based on a prior history of repetitive brain trauma and at least one concussion, and a current mood disorder (depression, apathy, irritability, suicidal ideation), cognitive symptoms (memory loss, impaired executive function) or behavioral symptoms (disinhibition, aggression and increased violence) (Jordan, 2013).\n\nFrontal Temporal Dementia/Pick's disease subjects:\n\n* The participant is 50 years or older.\n* Participants have a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia (Neary, et al., 1998)\n\nHealthy Control subjects:\n\n* The participant is 18 - 85 years old.\n* Negative history of neurological or psychiatric illness based on evaluation by a research physician.\n* MMSE score must be 29 or above.\n\nExclusion Criteria:\n\nAll subjects will be excluded from participation for the following reasons:\n\n* The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.\n* The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).\n* The subject has evidence of a structural lesion on MRI that may interfere with interpretation of PET imaging.\n* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.\n* The subject has participated in another clinical study within the previous 30 days.\n* Pregnancy or women who are nursing or breastfeeding"}, 'identificationModule': {'nctId': 'NCT02103894', 'briefTitle': 'Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Molecular NeuroImaging'}, 'officialTitle': 'Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects', 'orgStudyIdInfo': {'id': 'MNI-777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]T807 ([18F]MNI-777)', 'description': 'At the \\[18F\\]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of \\[18F\\]MNI-777).', 'interventionNames': ['Drug: [18F]T807 ([18F]MNI-777)']}], 'interventions': [{'name': '[18F]T807 ([18F]MNI-777)', 'type': 'DRUG', 'otherNames': ['[18F]T807', '[18F]florbetapir', 'Amyvid', '[123I]β-CIT'], 'description': 'All enrolled subjects will undergo an \\[18F\\]MNI-777 PET imaging visit. For individuals with AD or CTE, \\[18F\\]florbetapir imaging may also be performed to serve as a means of correlating disease severity by evaluating the relationship of β-amyloid uptake (measured by \\[18F\\]florbetapir imaging) and tau protein uptake (measured by \\[18F\\]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, \\[123I\\]β-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.', 'armGroupLabels': ['[18F]T807 ([18F]MNI-777)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Molecular NeuroImaging, LLC', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molecular NeuroImaging', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Danna Jennings', 'investigatorAffiliation': 'Molecular NeuroImaging'}}}}