[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03809351":3,"trial-entities:NCT03809351":77,"trial-summary:NCT03809351":81},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":65,"overall_officials":74,"references":75,"see_also_links":76},"NCT03809351","IRB-300002780 R19-006","UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy","RECRUITING","2028-07","2026-08","2026-08-12","2020-07-08","University of Alabama at Birmingham","OTHER",true,"The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET\u002FMRI study will also be enrolled in an ongoing \\[C-11\\]PiB-PET\u002FMRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.",null,[18],"Alzheimer Disease",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"PHASE1",{"count":25,"type":26},160,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","[F-18]AV-1451-PET","All study participants will undergo brain imaging with \\[F-18\\]AV-1451-PET\u002FMRI. \\[F-18\\]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.",[33],"[F-18]AV-1451-PET\u002FMRI",[35],{"measure":36,"description":37,"timeFrame":38},"Measurement of pathological tau deposition in the brain.","The amount and regional distribution of pathological tau in the brains of study participants will be measured with \\[F-18\\]AV-1451-PET\u002FMRI using standardized uptake value ratios (SUVRs) derived from the PET images.","5 years",[],"ALL","50 Years",{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.\n2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.\n3. Negative urine or serum hCG test within 2 days of \\[F-18\\]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.\n\nExclusion Criteria:\n\n1. Meets any exclusion criteria for the UAB-ADC study.\n2. Inability or contraindication for undergoing MRI and\u002For PET imaging\n3. Inability to participate in the imaging studies due to severity of dementia",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":51,"status":7,"city":52,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":62},"UAB","Birmingham","Alabama","35233","United States",[57],{"name":58,"role":59,"phone":60,"email":61},"April Riddle","CONTACT","2059346504","ariddle@uabmc.edu",{"lat":63,"lon":64},33.52066,-86.80249,[66,70],{"name":67,"role":59,"phone":68,"email":69},"Chinara Dosse","(205) 934-4501","cdosse@uabmc.edu",{"name":71,"role":59,"phone":72,"email":73},"Carol Chambless","(205) 975-9569","cchambless@uabmc.edu",[],[],[],{"nct_id":4,"conditions":78,"biomarkers":80},[79],"Alzheimer's Disease",[],{"nct_id":4,"found":14,"summary":82,"prompt_version":91},{"design":83,"status":84,"heading":6,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is an interventional study with a planned enrollment of 160 participants. The phase of the study is not specified.","completed","This study is looking at Alzheimer's disease and how a protein called tau builds up in the brain. Researchers will use a special brain scan called [F-18]AV-1451-PET\u002FMRI to measure the amount and location of abnormal tau protein. This scan uses a substance called [F-18]AV-1451. The goal is to understand how tau levels in the brain relate to a person's background, health information, genetics, and thinking abilities. The study will also look at how race and risk factors for blood vessel problems might affect tau levels and thinking. You can join if you are 50 years or older and are already part of other UAB-ADC studies. The study aims to measure tau deposition over 5 years.","The primary endpoint, measurement of pathological tau deposition, will be measured at 5 years.",115,"All study participants will undergo brain imaging with [F-18]AV-1451-PET\u002FMRI. This involves a PET scan and an MRI scan.","Not stated in the trial record.",[30],"v2"]