[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525423":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":44,"centralContacts":49,"locations":57,"responsibleParty":72,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Skane University Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitively unimpaired individuals with preclinical Alzheimer's disease",null,"75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.",[13,14,15,16,17],"Diagnostic Test: Plasma tau","Diagnostic Test: Plasma β-Amyloid 42\u002F40 (Aβ42\u002FAβ40)","Diagnostic Test: Flutemetamol F18 Injection","Diagnostic Test: [18F]-RO6958948 Injection","Diagnostic Test: Magnetic resonance imaging (MRI)",{"label":19,"type":10,"description":20,"interventionNames":21},"Cognitively unimpaired individuals without preclinical Alzheimer's disease.","25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.",[13,14,15,16,17],[23,28,32,36,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Plasma tau","Plasma levels of different p-tau and np-tau species",[9,19],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Plasma β-Amyloid 42\u002F40 (Aβ42\u002FAβ40)","Plasma levels of Aβ42\u002FAβ40 ratio",[9,19],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Flutemetamol F18 Injection","Positron emission tomography (PET) imaging of amyloid-β plaques",[9,19],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"[18F]-RO6958948 Injection","PET imaging of Tau aggregates",[9,19],{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Magnetic resonance imaging (MRI)","Different MRI sequences relevant for brain imaging",[9,19],[45],{"name":46,"affiliation":47,"role":48},"Erik Stomrud, MD, PhD","Skane University Hospital and Lund University","PRINCIPAL_INVESTIGATOR",[50,54],{"name":46,"role":51,"phone":52,"phoneExt":10,"email":53},"CONTACT","+46 40 33 10 00","erik.stomrud@med.lu.se",{"name":55,"role":51,"phone":52,"phoneExt":10,"email":56},"Niklas Mattsson-Carlgren, MD, PhD","niklas.mattsson-carlgren@med.lu.se",[58],{"facility":59,"status":60,"city":61,"state":10,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Skåne University Hospital","RECRUITING","Malmö","Sweden","SE",{"type":65,"coordinates":66},"Point",[67,68],13.00073,55.60587,{"lat":68,"lon":67},[71],{"name":46,"role":51,"phone":10,"phoneExt":10,"email":10},{"type":48,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Erik Stomrud","M.D., PhD",[76],{"name":77,"class":6},"Lund University","100525423","the-swedish-biofinder---preclinical-ad-study-100525423",false,"NCT06121544","The Swedish BioFINDER - Preclinical AD Study","Inclusion Criteria:\n\n1. Age 50-80\n2. Individuals aged 50-60 require at least one of the following risk factors for AD:\n\n   1. Known apolipoprotein E (APOE) -ε4 carrier\n   2. Known 1st degree family history of dementia or severe memory loss with onset prior to 75.\n   3. Known amyloid brain pathology by either CSF or PET scan.\n3. Mini-Mental State Examination (MMSE) ≥26 (aged \\>65); MMSE ≥27 (aged 50-65).\n4. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.\n5. Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests.\n\n6a. Preclinical Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans.\n\n6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease biomarkers or Aβ-PET scans.\n\nExclusion Criteria:\n\n1. Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n2. History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease.\n3. Major depression, bipolar disorder, or recurrent psychotic disorders within the past year.\n4. History of alcohol and\u002For substance abuse or dependence within the past year.\n5. Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.\n6. Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).","ALL","50 Years","80 Years",{"count":88,"type":89},800,"ESTIMATED","OBSERVATIONAL","This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3\u002F4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.",[93,94,95],"Alzheimer Disease","Mild Cognitive Impairment","Mild Dementia",[97],"Preclinical Alzheimer, early diagnosis, biomarkers, plasma, CSF, PET","2026-04-01",{"date":100,"type":101},"2026-04-06","ACTUAL",{"date":103,"type":101},"2022-04-01",{"date":105,"type":89},"2026-12-31",{"name":5,"class":6},1]