[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03503331":3,"trial-entities:NCT03503331":92,"trial-summary:NCT03503331":96},{"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":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":14,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":79,"overall_officials":88,"references":90,"see_also_links":91},"NCT03503331","IRB-300001005","UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy","RECRUITING","2028-10","2026-08","2026-08-12","2018-04-20","University of Alabama at Birmingham","OTHER",null,"The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \\[C-11\\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \\[C-11\\]PiB-PET, and cognitive status will be the primary outcome of this imaging study.","The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \\[C-11\\]PiB in participants in the UAB-ADC cohort. The amount and distribution of \\[C-11\\]PiB 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 amyloid levels measured with \\[C-11\\]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from \\[C-11\\]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.",[18],"Alzheimer Disease",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"PHASE2",{"count":25,"type":26},160,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","[C-11]PiB-PET\u002FMRI","All study participants will undergo brain imaging with \\[C-11\\]PiB-PET\u002FMRI. \\[C-11\\]PiB is a PET imaging agent used primarily to measure the amount of abnormal protein (called beta-amyloid) in the brain. The investigator will also use this tracer to evaluate regional cerebral blood flow.",[30],[34],{"measure":35,"description":36,"timeFrame":37},"Measurement of pathological beta-amyloid in the brain","The amount of pathological beta-amyloid in the brains of study participants will be measured with \\[C-11\\]PiB-PET\u002FMRI using standardized uptake value ratios (SUVRs) derived from the PET images.","5 years",[],"ALL","50 Years",true,{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n\\- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).\n\n2\\. Negative urine or serum B-hCG test within 2 days of \\[C-11\\]PiB 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 (IRB-300000169).\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":76},"University of Alabama at Birmingham Medical Center","Birmingham","Alabama","35294","United States",[57,62,65,68,70,72,74],{"name":58,"role":59,"phone":60,"email":61},"Jonathan McConathy, MD","CONTACT","205-996-7115","jmcconathy@uabmc.edu",{"name":63,"role":64},"Jonathan McConathy, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":66,"role":67},"Geldmacher David, MD","SUB_INVESTIGATOR",{"name":69,"role":67},"Lapi Suzanne, PhD",{"name":71,"role":67},"Jeffers Charlotte Denise, RPh",{"name":73,"role":67},"Natelson Marissa, MD",{"name":75,"role":67},"Roberson Erik, MD, PhD",{"lat":77,"lon":78},33.52066,-86.80249,[80,84],{"name":81,"role":59,"phone":82,"email":83},"Chinara Dosse","(205) 975-7017","cdosse@uabmc.edu",{"name":85,"role":59,"phone":86,"email":87},"Evan Hudson","205-934-6499","evanhudson@uabmc.edu",[89],{"name":58,"affiliation":12,"role":64},[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Alzheimer's Disease",[],{"nct_id":4,"found":41,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll 160 participants. It involves a specific brain imaging procedure.","completed","UAB Alzheimer's Disease Center Imaging Substudy","This study is looking at people who are already part of the UAB Alzheimer's Disease Center (ADC) study. Researchers want to understand more about Alzheimer's disease by using a special brain scan called [C-11]PiB-PET\u002FMRI. This scan helps measure a protein called beta-amyloid, which is linked to Alzheimer's. The study aims to see how beta-amyloid levels relate to a person's race, risk factors for blood vessel problems, and thinking abilities. To join, you must already be enrolled in the UAB-ADC study and be at least 50 years old. The main goal is to measure beta-amyloid in the brain over 5 years.","The primary endpoint, measurement of pathological beta-amyloid in the brain, will be taken at 5 years.",100,"All participants will undergo a brain imaging scan using [C-11]PiB-PET\u002FMRI. Women of childbearing potential will need a negative pregnancy test before the scan.","Not stated in the trial record.",[30],"v2"]