[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06547099":3,"trial-entities:NCT06547099":125,"trial-summary:NCT06547099":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":69,"sex":70,"minimum_age":71,"maximum_age":15,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":85,"locations":88,"central_contacts":106,"overall_officials":108,"references":113,"see_also_links":124},"NCT06547099","202405156","Study to Understand Novel Biomarkers in Researching Dementia","Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis","RECRUITING","2028-12","2026-01","2026-01-16","2024-08-14","Washington University School of Medicine","OTHER",null,"The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.","All participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. Depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for Alzheimer's disease as determined by the participant's medical provider.",[19,20,21],"Alzheimer Disease","Mild Cognitive Impairment","Dementia",[],"OBSERVATIONAL",[],{"count":26,"type":27},1800,"ESTIMATED",[29,35,39,44],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","Clinical tau PET","Tau PET (flortaucipir)",[34],"Cognitively impaired",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Clinical amyloid test","Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test",[34],{"type":14,"name":40,"description":41,"armGroupLabels":42},"Research blood collection","Research blood assays for amyloid, tau, and neurodegeneration",[34,43],"Cognitively normal",{"type":14,"name":45,"description":46,"armGroupLabels":47},"Cognitive assessments","Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)",[34,43],[49,52,54,56,58,60,63,65,67],{"measure":50,"timeFrame":51},"Area under the curve (AUC) of plasma amyloid-beta 42\u002F40 in predicting amyloid PET status","Baseline",{"measure":53,"timeFrame":51},"Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status",{"measure":55,"timeFrame":51},"Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status",{"measure":57,"timeFrame":51},"Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status",{"measure":59,"timeFrame":51},"Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status",{"measure":61,"timeFrame":62},"Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis","Baseline, 1 year, 2 years, 3 years, 4 years, 5 years",{"measure":64,"timeFrame":62},"Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis",{"measure":66,"timeFrame":62},"Area under the curve (AUC) of plasma amyloid-beta 42\u002F40 in predicting clinical diagnosis",{"measure":68,"timeFrame":62},"Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis",[],"ALL","60 Years",true,{"inclusion":74,"exclusion":78,"raw_text":84},[75,76,77],"At least 60 years of age","80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and\u002For provider","All SEABIRD participants will be invited to participate regardless of their cognitive status",[79,80,81,82,83],"Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment","Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection","Taking a disease-modifying drug for AD at time of enrollment","Blood transfusion in the last three months","Unwilling or unable to participate in all study activities","Inclusion Criteria:\n\n* At least 60 years of age\n* 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and\u002For provider\n* All SEABIRD participants will be invited to participate regardless of their cognitive status\n\nExclusion Criteria:\n\n* Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment\n* Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection\n* Taking a disease-modifying drug for AD at time of enrollment\n* Blood transfusion in the last three months\n* Unwilling or unable to participate in all study activities",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":13,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":103},"St Louis","Missouri","63110","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Lisa Soke","CONTACT","314-747-4857","sunbirdstudy@wustl.edu",{"name":101,"role":102},"Randall Bateman, MD","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},38.62727,-90.19789,[107],{"name":96,"role":97,"phone":98,"email":99},[109,110],{"name":101,"affiliation":13,"role":102},{"name":111,"affiliation":13,"role":112},"David Carr, MD","STUDY_DIRECTOR",[114,118,121],{"pmid":115,"type":116,"citation":117},"37204806","BACKGROUND","Li M, Li Y, Schindler SE, Yen D, Sutcliffe S, Babulal GM, Benzinger TLS, Lenze EJ, Bateman RJ. Design and feasibility of an Alzheimer's disease blood test study in a diverse community-based population. Alzheimers Dement. 2023 Dec;19(12):5387-5398. doi: 10.1002\u002Falz.13125. Epub 2023 May 19.",{"pmid":119,"type":116,"citation":120},"36087307","Janelidze S, Bali D, Ashton NJ, Barthelemy NR, Vanbrabant J, Stoops E, Vanmechelen E, He Y, Dolado AO, Triana-Baltzer G, Pontecorvo MJ, Zetterberg H, Kolb H, Vandijck M, Blennow K, Bateman RJ, Hansson O. Head-to-head comparison of 10 plasma phospho-tau assays in prodromal Alzheimer's disease. Brain. 2023 Apr 19;146(4):1592-1601. doi: 10.1093\u002Fbrain\u002Fawac333.",{"pmid":122,"type":116,"citation":123},"34542571","Janelidze S, Teunissen CE, Zetterberg H, Allue JA, Sarasa L, Eichenlaub U, Bittner T, Ovod V, Verberk IMW, Toba K, Nakamura A, Bateman RJ, Blennow K, Hansson O. Head-to-Head Comparison of 8 Plasma Amyloid-beta 42\u002F40 Assays in Alzheimer Disease. JAMA Neurol. 2021 Nov 1;78(11):1375-1382. doi: 10.1001\u002Fjamaneurol.2021.3180.",[],{"nct_id":4,"conditions":126,"biomarkers":129},[127,21,128],"Alzheimer's Disease","Mild cognitive disorder",[],{"nct_id":4,"found":72,"summary":131,"prompt_version":141},{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an observational study, not testing a new treatment, and plans to include 1800 participants. It is not specified if participants are randomly assigned to groups or if the study is blinded.","completed","Understanding Biomarkers in Alzheimer's Disease and Dementia","This observational study aims to understand how well blood tests can detect and predict Alzheimer's disease (AD) and related conditions like mild cognitive impairment (MCI) and dementia. Researchers are looking at the relationship between specific markers in the blood (amyloid, tau, and signs of neurodegeneration) and the presence of AD in the brain, as well as changes in thinking and memory. You might receive tests like a tau PET scan (using flortaucipir), an amyloid PET scan (using florbetapir), or blood\u002Fspinal fluid tests for amyloid. The study will measure how accurately blood tests for amyloid-beta 42\u002F40 and p-tau217 predict the results of amyloid and tau PET scans. People aged 60 and older, with or without memory issues, can join this study, which plans to enroll 1800 participants.","Not specified.",126,"You will have an initial visit for blood collection and cognitive assessments. Depending on your cognitive assessment results, you may have follow-up visits annually or every two years for more cognitive tests, blood collections, and potential clinical tests for Alzheimer's disease.","Not stated in the trial record.",[],"v2"]