[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03372317":3,"trial-entities:NCT03372317":98,"trial-summary:NCT03372317":102},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":68,"locations":71,"central_contacts":89,"overall_officials":93,"references":96,"see_also_links":97},"NCT03372317","AAAR6959","Tau PET in Imaging and Cognition: Healthy Adults From 55-90","Tau Positron Emission Tomography (PET) in Imaging and Cognition","RECRUITING","2027-12","2026-02","2026-02-11","2018-06-01","Yaakov Stern","OTHER",false,"The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then examine the interactions between differential tau burden and performance on cognitive tasks, functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive and behavioral measures. By investigating these relationships, the investigators hope to understand the cognitive and behavioral outcomes of tau deposition found in specific brain regions in cognitively normal\u002Fmildly cognitively impaired adults. Furthermore, the study aims to examine how the presence of tau may contribute to the risk of subsequent cognitive decline, neurodegeneration, and dementia.","Many cognitively healthy older adults have, upon post mortem evaluations, been found to have varying amounts of neurofibrillary tangles (tau) and beta-amyloid plaque deposits, which are the hallmark brain pathologies known to be associated with Alzheimer's disease and various other dementias. While some with these pathologies may not clinically express cognitive decline or dementia in their lifetime, human post-mortem studies suggest that increasing neurofibrillary tangle density correlates with neurodegeneration and cognitive impairment.\n\nImaging tauopathy in-vivo provides an opportunity to examine neurocognitive correlates of differential levels of tauopathy in the brain, allowing to further qualify pre-clinical states of cognitive impairment. The investigators aim to investigate possible protective mechanisms, such as cognitive reserve, that may modulate the relationship between tauopathy and cognitive decline.",[19,20],"Mild Cognitive Impairment","Aging",[22,23,24],"Tau","MK-6240","Cognition","OBSERVATIONAL",null,[],{"count":29,"type":30},105,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","18F-MK-6240","Results of the 18F-MK-6240 PET scan will be correlated with other observations.",[37],"Non-demented elders",[39],"6-[18F]Fluoro-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine",[41,45,47],{"measure":42,"description":43,"timeFrame":44},"Total number of individuals with tau present","Based on the scans, the total number of subjects with identifiable tau in their scans will be measured.","Up to 5 years",{"measure":24,"description":46,"timeFrame":44},"Relation of Tau PET to measures of cognition such as memory and reasoning",{"measure":48,"description":49,"timeFrame":44},"Functional imaging (fMRI)","Relation of Tau PET to imaging acquired during task performance",[],"ALL","55 Years","90 Years",true,{"inclusion":56,"exclusion":61,"raw_text":67},[57,58,59,60],"Aged 55-90","Previously received an amyloid PET scan","Residing near Columbia University Medical Center","Must be willing and able to participate",[62,63,64,65,66],"Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)","Pregnancy","Lactating Women","Current, past, or anticipated exposure to radiation","Significant active physical illness","Inclusion Criteria:\n\n* Aged 55-90\n* Previously received an amyloid PET scan\n* Residing near Columbia University Medical Center\n* Must be willing and able to participate\n\nExclusion Criteria:\n\n* Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)\n* Pregnancy\n* Lactating Women\n* Current, past, or anticipated exposure to radiation\n* Significant active physical illness",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"Columbia University Medical Center","New York","10032","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Ashley Mensing, BS","CONTACT","212-305-6314","ao2454@cumc.columbia.edu",{"name":84,"role":85},"Yaakov Stern, PhD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},40.71427,-74.00597,[90],{"name":91,"role":80,"phone":81,"email":92},"Reshma Babukutty","rb2996@cumc.columbia.edu",[94],{"name":84,"affiliation":95,"role":85},"Columbia University",[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Mild cognitive disorder",[],{"nct_id":4,"found":54,"summary":103,"prompt_version":113},{"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 with a planned enrollment of 105 participants, aged 55-90.","completed","Tau PET Imaging and Cognition Study for Healthy Adults and Those with Mild Cognitive Impairment","This observational study is looking at how a new imaging agent, 18F-MK-6240, can help detect tau protein buildup in the brain. Tau is a protein linked to Alzheimer's disease and other dementias. Researchers will use PET scans with 18F-MK-6240 to see how much tau is present in people aged 55-90, including those with normal thinking abilities and those with mild cognitive impairment (MCI). They will then compare these tau levels with how well people perform on memory and thinking tests, and with brain activity seen on fMRI scans. The goal is to understand how tau affects thinking and behavior, and if it increases the risk of future memory decline. The study plans to enroll 105 participants, but its current status is unclear.","Participants will be followed for up to 5 years to assess tau presence, cognition, and functional imaging.",122,"You would undergo PET scans using 18F-MK-6240, cognitive tests, and fMRI scans. The study will track these measures for up to 5 years.","Not stated in the trial record.",[34],"v2"]