[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603763":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Group","OTHER","Stratified by Primary Care Physician (PCP) versus Secondary\u002FTertiary Physician (S\u002FTCP)\n\nPatient participants in the interventional group will undergo P-tau217 testing.",[13],"Diagnostic Test: P-tau217",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard of Care Group","Stratified by PCP versus S\u002FTCP\n\nPatient participants in the standard of care group (SOC) will not undergo sponsor-provided P-tau217 testing.",[18],"Other: Standard of Care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","P-tau217","Blood biomarker testing",[9],null,{"type":10,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of Care","Standard of care",[15],[31],{"name":32,"affiliation":5,"role":33},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","CONTACT","1-317-615-4559","LillyTrials@Lilly.com",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"SiteRx Virtual Site","RECRUITING","New York","10013","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.00597,40.71427,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":61},"Ira Goodman","888-397-0072","ira@site.siterx.com",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100603763","a-study-evaluating-the-impact-of-p-tau217-blood-biomarker-testing-on-early-evaluation-and-management-of-patients-presenting-with-cognitive-complaint-100603763",false,"NCT07140744","A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint","A Prospective Diagnostic Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint in Primary and Secondary\u002FTertiary Care","Inclusion Criteria:\n\nHealth Care Provider (HCP) Definitions\n\n* Primary care physician (PCPs): physicians such as family medicine practitioners and internists who do not specialize in neurological care.\n* Secondary care physicians (SCPs): physicians such as geriatricians or neurologists who see patients for specific reasons.\n* Tertiary care physicians (TCPs): specialty neurologists who focus on certain neurological conditions.\n\nHCP Participant Selection Criteria\n\n* HCP inclusion criterion for each category of HCP is as follows:\n\n  * Group 1: PCPs who routinely evaluate and manage patients over the age of 50 in a family practice or internist setting.\n  * Group 2: SCPs and TCPs with experience diagnosing and treating patients with cognitive impairment and dementia.\n\nAdditional inclusion criteria applying to HCPs in the interventional group:\n\n* Must be willing to review educational materials provided by the study sponsor, before enrolling patients.\n\nPatient Participant Criteria\n\n* Participants in the interventional group are eligible to be included in the study only if all the following criteria apply:\n\n  * Are capable of giving, and have given, signed informed consent.\n  * Have venous access sufficient to allow the protocol-required blood sampling.\n  * Are reliable, willing, and able to make themselves available for the duration of the study and are willing to follow study procedures.\n\nDisease-specific Characteristics\n\n* Present to the HCP with 1 or more subjective cognitive impairment complaints (SCIC) in the 4 weeks prior to identification: for example, worsening of memory, misplacing items, difficulty concentrating, or new challenges with problem solving.\n\nPatient Participant Exclusion Criteria:\n\n* In the 18 months prior to identification have prior or associated HCP-ordered referral or prior prescription of drug therapies, for the SCIC\n* Participants with previous amyloid- or tau-specific tests, defined as\n\n  * Amyloid position emission tomography (PET)\n  * Tau PET\n  * Cerebral spinal fluid (CSF) tests for amyloid beta (Aβ) and\u002For tau biomarkers, or\n  * Blood tests for Aβ and\u002For tau biomarkers\n* Has a current serious or unstable illness that in the enrolling investigator's opinion could interfere with completion of the study or have a life expectancy of less than 1 year.\n* Has a known brain lesion, pathology, or prior alternative diagnosis that could explain the participant's clinical presentation.","ALL","50 Years",{"count":74,"type":75},7000,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of the study is to measure the difference in the proportion of participants with prespecified patient management actions between a tested interventional group and a control group.",[81],"Subjective Cognitive Impairment",[83,84,85],"Diagnostic utility","Blood biomarkers","Blood diagnostics","2025-10-30",{"date":88,"type":89},"2025-11-03","ACTUAL",{"date":91,"type":89},"2025-08-22",{"date":93,"type":75},"2027-10",{"name":5,"class":6},1]