Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-09 @ 2:33 PM
Study NCT ID:
NCT02377206
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroinflammation and Cognitive Decline in Alzheimer Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint', 'timeFrame': 'inclusion and 24 months'}], 'secondaryOutcomes': [{'measure': 'Relationship passessment between [18F]DPA-714 fixing', 'timeFrame': 'Inclusion and 34 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET', '[18F]DPA-714', 'cognitive decline'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '21911694', 'type': 'BACKGROUND', 'citation': 'Schmidt C, Wolff M, Weitz M, Bartlau T, Korth C, Zerr I. Rapidly progressive Alzheimer disease. Arch Neurol. 2011 Sep;68(9):1124-30. doi: 10.1001/archneurol.2011.189.'}, {'pmid': '19043645', 'type': 'BACKGROUND', 'citation': "Soto ME, Andrieu S, Arbus C, Ceccaldi M, Couratier P, Dantoine T, Dartigues JF, Gillette-Guyonnet S, Nourhashemi F, Ousset PJ, Poncet M, Portet F, Touchon J, Vellas B. Rapid cognitive decline in Alzheimer's disease. Consensus paper. J Nutr Health Aging. 2008 Dec;12(10):703-13. doi: 10.1007/BF03028618."}, {'pmid': '17215578', 'type': 'BACKGROUND', 'citation': "Helmer C, Andrieu S, Peres K, Orgogozo JM, Vellas B, Dartigues JF; REAL.fr Group. Predictive value of 6-month decline in ADAS-cog for survival without severe Alzheimer's disease. Dement Geriatr Cogn Disord. 2007;23(3):168-74. doi: 10.1159/000098516. Epub 2007 Jan 11."}, {'pmid': '22972646', 'type': 'BACKGROUND', 'citation': "Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. doi: 10.1212/WNL.0b013e31826c1b9d. Epub 2012 Sep 12."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of \\[18F\\]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).", 'detailedDescription': 'The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of \\[18F\\]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).\n\n(DPA-714 : N,N-diethyl-2-\\[4-(2-fluoroethoxy)phenyl\\]-5,7-dimethylpyrazolo\\[1,5-a\\]pyrimidine-3-acetamide)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent\n* Age more than 50 years (included)\n* necessary knowledge of French (write and oral) to do neuropsychological tests\n* Study level upper (or equal) than 7 years (considering first year of grammar-school as start)\n* People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)\n* Social security affiliation.\n\nExclusion Criteria:\n\n* MMSE score lower than 15 and upper or equal to 26\n* Evolutive disease which could possibly had consequences on central nervous system\n* Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L\n* Chronic use of alchohol and/or drug\n* Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18\n* Surgical or medical condition in the last 3 months\n* Long term treatment which could possibly interfere with inflammatory process (especially the month before PET \\[18F\\]DPA-714 imaging).\n* Treatment by N-Methyl-D-Aspartate antagonist\n* Treatment by Minocycline\n* Treatment by benzodiazepine (especially the month before PET \\[18F\\]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted)\n* Anomaly at neurological examination which is not a classical symptom\n* Contraindication to magnetic resonance imaging (RMI)\n* Florbetapir\\[18F\\] hypersensibility\n* Participation to an other experimental protocol with drug.\n* people under guardianship"}, 'identificationModule': {'nctId': 'NCT02377206', 'acronym': 'NICAD', 'briefTitle': 'Neuroinflammation and Cognitive Decline in Alzheimer Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714', 'orgStudyIdInfo': {'id': 'PRTS13-CH / NICAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alzheimer Disease', 'description': 'Alzheimer Disease People ADAS-Cog evaluation PET imaging with \\[18F\\]DPA-714', 'interventionNames': ['Other: ADAS-Cog evaluation']}], 'interventions': [{'name': 'ADAS-Cog evaluation', 'type': 'OTHER', 'description': '\\[18F\\]DPA-714 PET imaging', 'armGroupLabels': ['Alzheimer Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'university hospital of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'University Hospital of Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Vincent CAMUS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}