{"doc_desc":{"title":"Longitudinal Study on Multimodal Imaging for Early-Stage Alzheimer's Disease: Biomarkers for Detection and Progression and Physiopathological Mechanisms","idno":"FRESH-PEF7969-en","producers":[{"name":"Ga\u00ebl CHETELAT","affiliation":"GIP CYCERON"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF7969-en","IDno":{"metadata_no":[{"agency":"PEF","code":"7969"},{"agency":"FReSH","code":"FRESH-PEF7969"}]},"title":"Longitudinal Study on Multimodal Imaging for Early-Stage Alzheimer's Disease: Biomarkers for Detection and Progression and Physiopathological Mechanisms","alternate_title":"IMAP+"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Ga\u00ebl;CHETELAT","PILabo":"","affiliationName":"GIP CYCERON","extlink":[{"title":"ORCID","uri":"0000-0002-4889-7932","role":"pi id"},{"title":"IdRef","uri":"068674961","role":"pi id"},{"title":"SIREN","uri":"180089187","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"chetelat@cyceron.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"sponsor id"},{"title":"SIREN","uri":"261400931","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Ga\u00ebl;CHETELAT","email":"chetelat@cyceron.fr","type":"contact","affiliationName":"GIP CYCERON","contactPointLabo":"","extlink":[{"uri":"180089187","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Genetics"},{"keyword":"early diagnosis"},{"keyword":"normal ageing"},{"keyword":"neuroimaging"},{"keyword":"PET"},{"keyword":"MRI"},{"keyword":"fMRI"},{"keyword":"neuroanatomy"},{"keyword":"molecular imaging"},{"keyword":"FDG-PET"},{"keyword":"Alzheimer's disease"},{"keyword":"biomarkers"},{"keyword":"AV45"}],"topics":[{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Psychiatry","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Alzheimer disease","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1611724421","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"General objective: To study and compare the effectiveness of different in vivo markers to predict cognitive decline in patients at risk of developing Alzheimer's disease through neuroimaging, neuropsychology and biology measures. Secondary objectives: To study: i) Deterioration in NORMA subjects, as well as SCI, MCI, AD and SAND patients compared with healthy subjects of the same age; ii) Deterioration in E4 allele and apolipoprotein E (ApoE) carriers compared to non-carriers; iii) Cerebral and cognitive changes during normal ageing; iv) Progress and dynamics of different biomarkers during follow-up. To study the links between different deterioration profiles (intra-modality comparison and correlation), as well as differences in inter-group progression profiles.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2019-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Education level equal to 7 years or higher, native language is French, signed informed consent, medical, neurological and neuroimaging tests, as well as neuropsychological diagnostic test battery.  Control subjects: normal performance according to age and education level in all diagnostic battery tests. Middle-aged (40-59 years old): no memory complaints. Elderly (aged 60+): living at home, independent, no memory complaints.  NORMA (aged 18+) with identified disease, carriers of  mutated gene associated with familial early-onset AD, normal performance according to age and education level in all diagnostic battery tests.  Patients from memory assessment centres:  SCI (aged 50+), no memory complaints, normal performance according to age and education level in all diagnostic battery tests.  MCI meeting current amnestic MCI criteria with memory complaints, objective episodic memory deficits, performances in other cognitive functions where memory loss could occur, standard performance for age and education level in assessments of overall cognitive ability, independent in everyday life, no dementia according to DSM-IV criteria and no probable AD according to NINCDS-ADRDA criteria.  Alzheimer's patients meeting NINCDS-ADRDA criteria for probable AD with abnormal overall cognitive function and deficits in at least 2 cognitive areas identified by diagnostic battery tests; mild- to moderate-stage AD; accompanying party's signed informed consent.   SAND: CHU neurology departments - major episodic memory disorder that may be related to an objective deficit in executive function and standard performance for age and education level in all diagnostic battery tests measuring instrumental function.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"['NINCDS-ADRDA and DSM IV']","committee":"","governance":""}],"other_quality_statement":"['A diagnostic commission is organised on a monthly basis to report subject\/patient neuropsychological results, as well as their enrolment category, on a case-by-case basis. A multimodal meeting is organised on a monthly basis to report quality control results for imaging data. This trial is monitored by a person appointed by the CHU to ensure that exact, complete and reliable data is collected and to provide logistical support to research centres.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.) Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Recording (audio, video, electrophysiological, imaging)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"280"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"06-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"23-09-2020","isContributorPI":"No","contributorName":"Ga\u00ebl CHETELAT","contributorAffiliation":"GIP CYCERON","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28764930"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Subjects\/patients attend 6 examinations lasting approx. 2 hours + one blood sample. All examinations are conducted over a period of approx. 1 month. Subjects\/patients are treated by a contact person that monitors and supports them throughout the protocol. Collected data are reviewed in a multimodal meeting. Imaging data quality control results are also reported during this meeting. Collected data are reviewed during a diagnostic commission so that subject\/patient results, as well as their enrolment category, can be reported on a case-by-case basis.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"3\/4 of patients are from the region."},"dataTypes":{"clinicalDataDetails":"Clinical data collected through clinical records only include SCI, MCI, AD and SAND patients.","biologicalDataDetails":"Biological components (blood and CSF): i) blood test for fibrinolysis markers (tPA, ADAMTS-4); ii) AB40 and AB42 blood tests and AB40, AB42 CSF, tau protein and its phosphorylated form, iii) ApoE genotyping; iv) potential mutated gene sequencing in NORMA subjects","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}