Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 11:20 AM
Study NCT ID:
NCT00970333
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological Conditions
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': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530438', 'term': 'N-(2-((N-(4-phenoxypyridin-3-yl)acetamido)methyl)phenoxy)ethyl fluoride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]-FEPPA.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alzheimer disease', 'Parkinson disease', 'Multiple Sclerosis'], 'conditions': ['Alzheimer Disease', 'Parkinson Disease', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Ultimately a marker of microglial activation could be used for large-scale quantitative brain imaging trials in Alzheimer Disease (AD), Parkinson Disease (PD) or Multiple Sclerosis (MS), specifically to investigate the agent as an objective biomarker in treatments aimed at reducing inflammatory changes in these conditions. The significance of this work lies in applying state-of-art quantitative neuroimaging tools to develop a relevant biomarker in individuals with neurodegenerative diseases with the intention of using this efficiently in large clinical imaging trials.', 'detailedDescription': 'The adaptation of imaging agents like \\[18F\\]-FEPPA as a biomarker of microglial activation in neurodegenerative and neuroinflammatory diseases requires human validation studies. Expanding upon our previous work with B-amyloid ligands (123I-IMPY, 123I MNI-187) for AD and dopamine transporter ligands (123I B-CIT, Altropane) for PD, we desire to develop and characterize \\[18F\\]-FEPPA as a potential marker for microglial activation in association with neuronal damage that may be applicable to multiple neurodegenerative and inflammatory diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's disease patients will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:\n\n * The participant is 50 years or older.\n * Written informed consent is obtained.\n * Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.\n * Clinical Dementia Rating Scale score ≤ 2.\n * Modified Hachinski Ischemia Scale score of ≤ 4.\n * For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \\[18F\\]-FEPPA injection.\n\nExclusion Criteria:\n\n* Alzheimer's subjects will be excluded from participation for the following reasons:\n\n * The subject has a history of significant cerebrovascular disease.\n * The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness\n * The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.\n * Pregnancy\n\nInclusion Criteria:\n\n* The following criteria will be met for inclusion of PD subjects in this study:\n\n * The participant is 30 years or older.\n * Written informed consent is obtained.\n * Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).\n * Hoehn and Yahr ≤4.\n * For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \\[18F\\]-FEPPA injection.\n\nExclusion Criteria:\n\n* Parkinson's 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 evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.\n * Pregnancy\n\nInclusion Criteria:\n\n* Multiple Sclerosis Subject Selection. Subjects who have a clinical diagnosis of Multiple Sclerosis (MS) will be recruited for this study. The following criteria will be met for inclusion of MS subjects in this study:\n\n * The participant is 18 years or older.\n * Written informed consent is obtained.\n * Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005 Revised McDonald Criteria; Polman, et al., 2005).\n * Kurtzke Expanded Disability Status Scale (EDSS) ≤ 7.5.\n * For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \\[18F\\]-FEPPA injection.\n\nExclusion Criteria:\n\n* MS 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 evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.\n * Pregnancy"}, 'identificationModule': {'nctId': 'NCT00970333', 'briefTitle': 'Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Neurodegenerative Disorders'}, 'officialTitle': 'Evaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological Conditions', 'orgStudyIdInfo': {'id': 'FEPPA 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'assess [18F]-FEPPA PET imaging', 'interventionNames': ['Drug: [18F]-FEPPA']}], 'interventions': [{'name': '[18F]-FEPPA', 'type': 'DRUG', 'description': 'Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not \\>10% of 5 mCi limit) of \\[18F\\]-FEPPA followed by serial PET imaging', 'armGroupLabels': ['assess [18F]-FEPPA PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Instiute for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Danna Jennings, MD', 'investigatorAffiliation': 'Institute for Neurodegenerative Disorders'}}}}