[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435185":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":81,"collaborators":55,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":55,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":53,"whyStopped":55,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Hôpital le Vinatier","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Participant with psychiatric condition without cognitive impairment","EXPERIMENTAL","In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.",[13],"Diagnostic Test: blood sample taken",{"label":15,"type":10,"description":16,"interventionNames":17},"Participant with psychiatric condition with cognitive impairment","In the psychiatric condition group with cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria. To date, there are no clinical criteria for defining the dementia evolution of psychiatric disorders. The diagnosis of psychiatric disorder with cognitive involution is often made on the basis of subjective criteria or on the appreciation of health care teams. In the present study, cognitive involution will be defined by the occurrence of cognitive deterioration objectified by disturbed neuropsychological tests and the occurrence of progressive behavioral changes contrasting with the person's previous state and reported by the care team, a member of the family or by the patient himself. Cognitive involution must be accompanied by a decrease in autonomy with respect to the person's previous abilities.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Patients with biological Alzheimer's disease","Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Patient with fronto-temporal dementia","Probable or definite Fronto-temporal dementia, mostly behavioral variant of FTD (according to the diagnostic criteria for FTDb of Rascovsky, 2011) but Semantic Disease, Primary Progressive Non-Fluent Aphasia, Progressive Supra-Nuclear Palsy-DFT will be accepted if behavioral onset.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","blood sample taken","Comparaison of Neurofilament light chain serum concentration between the arms",[15,9,23,19],[33],"Cognitive tests and psychiatric questionnaires",[35],{"name":36,"affiliation":37,"role":38},"Jean-Michel DOREY, MD, PHD","CH le Vinatier","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Dorey Jean-Michel, MD,PHD","CONTACT","0437915249","+33","jean-michel.dorey@ch-le-vinatier.fr",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"SARTELET lydie","0437915531","lydie.sartelet@ch-le-vinatier.fr",[51,70],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"HCL Consultation mémoire Neurologique -Hôpital Neurologique","RECRUITING","Bron",null,"69677","France","FR",{"type":60,"coordinates":61},"Point",[62,63],4.91303,45.73865,{"lat":63,"lon":62},[66],{"name":67,"role":42,"phone":68,"phoneExt":44,"email":69},"Maïté Formaglio, PH","04.72.35.76.62","maite.formaglio@chu-lyon.fr",{"facility":71,"status":53,"city":54,"state":55,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Centre Hospitalier Le Vinatier","69678",{"type":60,"coordinates":74},[62,63],{"lat":63,"lon":62},[77,79],{"name":36,"role":42,"phone":78,"phoneExt":55,"email":45},"04 37 91 51 00",{"name":80,"role":38,"phone":55,"phoneExt":55,"email":55},"Jean-Michel DOREY, md, PHD",{"type":82,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100435185","neurofilament-light-chains-and-cognitive-impairment-in-chronic-psychiatric-disease-100435185",false,"NCT04946916","Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease","Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases","Nfl_COG","Inclusion Criteria:\n\n* haven given written consent\n\nParticipants with psychiatric conditions:\n\n* Schizophrenia (DSM-V criteria) with or without cognitive involution\n* Bipolar disorder (DSM-V criteria) with or without cognitive involution\n\nParticipants with neurodegenerative disease:\n\n* probable or definite FTD (Rascovsky criteria 2011)\n* Biological Alzheimer's disease with typical CSF (NIA-AA 2011)\n\nExclusion Criteria:\n\n* Uninterviewable patient and\u002For missing history\n* History of recent or previous head trauma with loss of consciousness\n* History of ischemic or hemorrhagic stroke\n* Chronic alcoholism \u002F chronic drug use\n* Progressive somatic pathology \u002F severe metabolic disorder \u002F poorly controlled epilepsy\n* Age \\\u003C 45 years\n* Age \\> 80 years\n* Electroconvulsive therapy for less than 6 months","ALL","45 Years","80 Years",{"count":95,"type":96},120,"ESTIMATED","INTERVENTIONAL",[99],"NA","The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.\n\nThe main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.\n\nA sub-part of this study will also focus on the retrospective analysis of the CSF\u002FPlasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.",[102,103,104,105],"Schizophrenia","Bipolar Disorder","Alzheimer Disease","FTD",[107,108],"dementia","biomarker","2025-07-23",{"date":111,"type":112},"2025-07-24","ACTUAL",{"date":114,"type":112},"2021-10-22",{"date":116,"type":96},"2028-03-22",{"name":5,"class":6},2]