Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02813434
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Amyloid Imaging Using Florbetapir (AV-45)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of positive amyloid retention', 'timeFrame': '12 months', 'description': 'determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment'}], 'secondaryOutcomes': [{'measure': 'Final diagnosis', 'timeFrame': '12 months', 'description': 'cognitive impairment or dementia'}]}, 'conditionsModule': {'keywords': ['Cerebral amyloid imaging', 'Florbetapir', '18F-AV-45', 'poststroke'], 'conditions': ['Dementia', 'Cognition Disorders']}, 'referencesModule': {'references': [{'pmid': '39648884', 'type': 'DERIVED', 'citation': 'Godefroy O, Trinchard N, Marchal E, Lamy C, Canaple S, Meyer ME, Roussel M, Wollenweber FA; IDEA3 Study Group. Do Amyloid Cerebral Deposits Influence the Long-Term Poststroke Cognitive Outcome?: The IDEA3 Study. Stroke. 2025 Jan;56(1):74-83. doi: 10.1161/STROKEAHA.124.049147. Epub 2024 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia', 'detailedDescription': 'This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia. This study stems from two converging objectives: (1) the need to refine characteristics of vascular cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke in consecutive patients according to a standardized international battery) coordinated by the Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city of Amiens) and the collaboration between neurology and imaging departments of Amiens University hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients suffering of parenchymal stroke visualized by imaging (MRI),\n2. patients suffering from cognitive impairment on the 6 months assessment (including GRECogVASC patients),\n3. age between 40 and 80 years,\n4. French-speaking,\n5. reliable informant,\n6. agreeing to participate in the study,\n7. affiliation to a social security system,\n\nExclusion Criteria:\n\n1. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile), or who are breast-feeding\n2. history of relevant severe drug allergy or hypersensitivity,\n3. patient receiving any investigational medications at least in the 30 last days,\n4. stroke affecting the cerebellum,\n5. mental retardation,\n6. illiteracy,\n7. dementia diagnosed before stroke,\n8. history of schizophrenia or psychiatric illness requiring a stay for \\> 2 days in a psychiatry unit,\n9. persons placed under judicial protection,\n10. comorbidities affecting cognition (respiratory, renal, liver, heart failure),\n11. persistent disturbance of consciousness defined by a score to item 1a of the National Institute of Health Stroke Scale (NIHSS) ≤ 1,\n12. contraindication to MRI.'}, 'identificationModule': {'nctId': 'NCT02813434', 'acronym': 'IDEA3', 'briefTitle': 'Cerebral Amyloid Imaging Using Florbetapir (AV-45)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia', 'orgStudyIdInfo': {'id': 'PI2013_843_0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Florbetapir', 'interventionNames': ['Biological: florbetapir']}], 'interventions': [{'name': 'florbetapir', 'type': 'BIOLOGICAL', 'description': '18F-AV-45 or 18F-Florbetapir', 'armGroupLabels': ['Florbetapir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier GODEFROY, MD, PhD', 'role': 'CONTACT', 'email': 'godefroy.olivier@chu-amiens.fr', 'phone': '+33 3 22 66 84 47'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Olivier Godefroy, MD, PhD', 'role': 'CONTACT', 'email': 'godefroy.olivier@chu-amiens.fr', 'phone': '+33 3 22 66 84 47'}], 'overallOfficials': [{'name': 'Olivier GODEFROY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}