[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648037":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":70,"collaborators":10,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Main Study Cohort",null,"2000 adult patients attending the Cognitive Disorders and Dementia Center (CDCD) at IRCCS San Raffaele Hospital with subjective or objective cognitive complaints of progressive and suspected neurodegenerative nature. All patients undergo annual blood sampling for 5 years in addition to standard clinical follow-up.",[13],"Procedure: Annual blood draw for plasma biomarker measurement",{"label":15,"type":10,"description":16,"interventionNames":17},"Validation Sub-study Cohort","150 patients from the main cohort who undergo lumbar puncture as part of their routine diagnostic workup and have CSF biomarkers for Alzheimer's disease available within 6 months of blood draw. Only those with CSF biomarkers confirming a biological diagnosis of Alzheimer's disease continue longitudinal follow-up in the sub-study.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Annual blood draw for plasma biomarker measurement","A blood sample is collected once per year for 5 years (additional procedure beyond standard clinical care) for measurement of plasma biomarkers including: Abeta40, Abeta42, Abeta42\u002FAbeta40 ratio, pTau-181, NfL, ApoE, ApoE4, GFAP, sTREM2, and other plasma neurodegeneration biomarkers. Blood draw is a routine clinical procedure with no specific contraindications. The only possible side effect is local hematoma at the puncture site. Plasma biomarker measurement is performed using a CE-marked medical device (Fujirebio, provided on free loan). Results do not modify the patient's standard diagnostic and therapeutic pathway.",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Massimo Filippi, Prof, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Federica Agosta, MD","CONTACT","0226433051","agosta.federica@hsr.it",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":10},"Giuseppe Magnani, MD",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)","RECRUITING","Milan","Milano","20132","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],12.59836,42.78235,{"lat":49,"lon":48},[52,53,54,55,57,58,60,62,64,66,68],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":35,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"name":30,"role":56,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":35,"role":56,"phone":10,"phoneExt":10,"email":10},{"name":59,"role":56,"phone":10,"phoneExt":10,"email":10},"Giordano Cecchetti, MD",{"name":61,"role":56,"phone":10,"phoneExt":10,"email":10},"Francesca Caso, MD",{"name":63,"role":56,"phone":10,"phoneExt":10,"email":10},"Roberto Santangelo, MD",{"name":65,"role":56,"phone":10,"phoneExt":10,"email":10},"Gioele Spinelli, MD",{"name":67,"role":56,"phone":10,"phoneExt":10,"email":10},"Giulia Rugarli, MD",{"name":69,"role":56,"phone":10,"phoneExt":10,"email":10},"Federico Coraglia, MD",{"type":27,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Massimo Filippi","Prof, MD","100648037","blood-tests-for-alzheimers-disease-can-plasma-biomarkers-diagnose-and-predict-disease-progression-100648037",false,"NCT07717567","Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression","The Diagnostic and Prognostic Role of Plasma Biomarkers in Alzheimer's Disease","BLAD","Inclusion Criteria (main study and sub-study):\n\n1. Age greater than or equal to 40 years (patients of childbearing age are admitted).\n2. Subjective or objective cognitive complaints, progressive in nature and of suspected neurodegenerative origin.\n3. Mini-Mental State Examination (MMSE) score greater than or equal to 18.\n\n   Additional inclusion criterion for the validation sub-study:\n4. Availability of CSF biomarkers for Alzheimer's disease within 6 months of the blood draw.\n\nExclusion Criteria (main study):\n\n1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings.\n2. Pregnancy or breastfeeding.\n3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders.\n4. Subjects who require a legal guardian or tutor.\n\nExclusion Criteria (validation sub-study):\n\n1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings.\n2. Pregnancy.\n3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders.\n4. Subjects who are unable to give informed consent and require a legal guardian or tutor.","ALL","40 Years",{"count":84,"type":85},2000,"ESTIMATED","OBSERVATIONAL","BLAD is a prospective, monocentric, observational epidemiological study with an additional procedure (annual blood draw) evaluating the diagnostic and prognostic performance of plasma biomarkers for Alzheimer's disease (AD) in a large cohort of patients attending the Cognitive Disorders and Dementia Center (CDCD) at IRCCS San Raffaele Hospital, Milan, Italy.\n\n2000 patients will be enrolled and followed annually for 5 years. A validation sub-study (150 patients) will compare plasma biomarkers against CSF biomarkers as the gold standard.\n\nThe study aims to establish plasma biomarkers as a less invasive and more cost-effective alternative to CSF analysis and amyloid-PET for the diagnosis and prognosis of AD.",[89,90,91,92,93],"Alzheimer Disease","Mild Cognitive Impairment","Subjective Cognitive Decline","Dementia","Cognitive Impairment",[95,96,97,98,99,100,101,102,103,90,91,92,104,105,106],"Alzheimer's disease","Plasma biomarkers","pTau-181","Abeta42","Abeta40","NfL","GFAP","sTREM2","ApoE","Blood biomarkers","Diagnostic accuracy","Prognosis","2026-07-16",{"date":109,"type":110},"2026-07-21","ACTUAL",{"date":112,"type":110},"2023-09-12",{"date":114,"type":85},"2032-06-01",{"name":5,"class":6},1]