[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05658913":3,"trial-entities:NCT05658913":97,"trial-summary:NCT05658913":101},{"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":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":86,"overall_officials":89,"references":95,"see_also_links":96},"NCT05658913","850679","Tau PET\u002FCT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)","RECRUITING","2029-12","2025-08","2025-09-05","2023-03-14","University of Pennsylvania","OTHER",false,"To collect Tau PET\u002FCT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.","This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants. All subjects will already have been enrolled in the MPC Study. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET\u002FCT scan imaging with AV-1451.",[18],"Alzheimer's Disease",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},100,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"otherNames":31},"DRUG","AV-1451","This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants.",[32],"7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole",[34],{"measure":35,"description":36,"timeFrame":37},"Clusters based on spatial pattern and extent of T-N Mismatch","We will test the hypotheses that spatial pattern and directionality of deviation in individual subjects of this metric will be correlated with modulatory factors such as non-AD pathology, brain resilience and vulnerability.\n\nSpecifically, we will use hierarchical clustering to determine groups based on degree and spatial pattern of mismatch between tau PET and cortical thickness measured by MRI. In these groups, we will compare amount of white matter hyperintensities, degree of brain aging, and both cross-sectional and longitudinal cognitive measures, with the primary measure being the Clinical Dementia Rating scale sum of boxes.","5 years",[],"ALL","18 Years","120 Years",{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n1. Enrolled in MPC study (Protocol 850160 at UPenn; Protocol 2022P002447 at MGH).\n2. Reliable study partner to accompany participant to the PET\u002FCT scan\n3. A brain MRI must be performed within 6 months prior to their study AV-1451 TAU PET\u002FCT scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.\n\nExclusion Criteria:\n\n1. Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.\n2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET\u002FCT scan.\n3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.\n4. Have a history of significant ongoing alcohol or substance abuse based on self- report.\n5. Female participants of child-bearing age will not be able to participate in this study, determined by self-report.",[47,48],"ADULT","OLDER_ADULT",[50,70],{"facility":51,"status":7,"city":52,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":67},"Massachusetts General Hospital","Boston","Massachusetts","02114-2696","United States",[57,62,65],{"name":58,"role":59,"phone":60,"email":61},"Bradford Dickerson, MD","CONTACT","617-726-6205","brad.dickerson@mgh.harvard.edu",{"name":63,"role":59,"phone":60,"email":64},"Erin Krahn","ekrahn@mgh.harvard.edu",{"name":58,"role":66},"PRINCIPAL_INVESTIGATOR",{"lat":68,"lon":69},42.35843,-71.05977,{"facility":12,"status":7,"city":71,"state":72,"zip":73,"country":55,"contacts":74,"geoPoint":83},"Philadelphia","Pennsylvania","19104",[75,79,81],{"name":76,"role":59,"phone":77,"email":78},"Jackie Lane","610-299-1243","Jacqueline.Lane@pennmedicine.upenn.edu",{"name":80,"role":66},"David Wolk, MD",{"name":82,"role":66},"Sandhitsu Das, PhD",{"lat":84,"lon":85},39.95238,-75.16362,[87],{"name":88,"role":59,"phone":77,"email":78},"Jacqueline Lane",[90,93],{"name":91,"affiliation":92,"role":66},"David A. Wolk","University of Pennsylvania Department of Neurology at the Perelman School of Medicine",{"name":94,"affiliation":92,"role":66},"Sandhitsu R. Das",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[18,99],"Mild cognitive disorder",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study involving 100 participants. It is a cross-sectional study, meaning data is collected at a single point in time.","completed","Tau PET\u002FCT Imaging in Alzheimer's Disease","This study, called MPC-TAU, is looking at older adults who have Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD). Researchers are using a special imaging scan called a PET\u002FCT with a substance called AV-1451. This scan helps them see \"tau pathology,\" which are abnormal proteins in the brain linked to Alzheimer's. The goal is to understand how these tau proteins relate to other information about your health and thinking abilities. This could help us learn more about the different ways Alzheimer's Disease can affect people. You can join if you are already part of the MPC study at UPenn or MGH, are between 18 and 120 years old, and have a study partner. The study's status is currently unclear.","The primary endpoint, looking at tau patterns, is measured at 5 years.",119,"You will provide informed consent and then undergo a PET\u002FCT scan with AV-1451. A brain MRI must have been performed within 6 months before your scan.","Not stated in the trial record.",[29],"v2"]