[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06129838":3,"trial-entities:NCT06129838":93,"trial-summary:NCT06129838":97},{"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":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":61,"locations":64,"central_contacts":83,"overall_officials":87,"references":91,"see_also_links":92},"NCT06129838","CS1P1-ADRD","Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1","RECRUITING","2027-05","2026-06","2026-06-09","2023-05-05","Washington University School of Medicine","OTHER",true,"This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \\[11C\\]-CS1P1 to identify inflammation in the brain by testing with healthy older adults and with cognitively impaired older adults.","The primary objective of this IND study is to further evaluate the \\[11C\\]-CS1P1 for PET imaging of S1P1 expression in healthy older adults and in adults with Alzheimer's disease and Related Dementia (ADRD). Investigators will complete imaging of the brain and neck in older adults with normal cognition and those with clinically diagnosed cognitive impairment from ADRD to characterize \\[11C\\]-CS1P1 uptake in the brain. Investigators will compare the normal cognition participants to patients with ADRD to collect preliminary data that will subsequently test the hypothesis that \\[11C\\]-CS1P1 uptake is elevated in patients with ADRD.",[18],"Alzheimer Disease",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},80,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":34},"DRUG","[11C]-CS1P1","Participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer \\[11C\\]-CS1P1. Participants will then undergo a brain \\[11C\\]-CS1P1 PET scan",[32,33],"Healthy participants","Participants with cognitive impairment (Alzheimer's disease)",[35],"Sphingosine 1 Phosphate 1",[37],{"measure":38,"description":39,"timeFrame":40},"PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.","To test the hypothesis that specific binding of \\[11C\\]-CS1P1 is elevated in participants with ADRD compared to healthy normal control participants.","Through study completion, an average of 1 year",[],"ALL","50 Years",{"inclusion":45,"exclusion":50,"raw_text":60},[46,47,48,49],"Male or female, any race;","Age ≥ 50 years;","Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure;","Additional inclusion for ADRD group: clinical diagnosis of mild cognitive impairment or early dementia due to ADRD, OR biomarker diagnosis of Alzheimer's disease, with or without symptoms.",[51,52,53,54,55,56,57,58,59],"Hypersensitivity to \\[11C\\]-CS1P1 or any of its excipients;","Contraindications to PET, CT, or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate;","Severe claustrophobia;","Women who are currently pregnant or breast-feeding;","Currently undergoing radiation therapy;","Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer);","Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including high grade heart block (type 2 or greater), unstable angina, or decompensated heart failure requiring hospitalization or Class III\u002FIV heart failure;","Moderate to Severe anemia with Hemoglobin \\\u003C than 9.9 in both males and females.","Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcdrh\u002Fcfdocs\u002Fcfcfr\u002FCFRSearch.cfm?FR=361.1","Inclusion Criteria:\n\n* Male or female, any race;\n* Age ≥ 50 years;\n* Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure;\n* Additional inclusion for ADRD group: clinical diagnosis of mild cognitive impairment or early dementia due to ADRD, OR biomarker diagnosis of Alzheimer's disease, with or without symptoms.\n\nExclusion Criteria:\n\n* Hypersensitivity to \\[11C\\]-CS1P1 or any of its excipients;\n* Contraindications to PET, CT, or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate;\n* Severe claustrophobia;\n* Women who are currently pregnant or breast-feeding;\n* Currently undergoing radiation therapy;\n* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer);\n* Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including high grade heart block (type 2 or greater), unstable angina, or decompensated heart failure requiring hospitalization or Class III\u002FIV heart failure;\n* Moderate to Severe anemia with Hemoglobin \\\u003C than 9.9 in both males and females.\n* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcdrh\u002Fcfdocs\u002Fcfcfr\u002FCFRSearch.cfm?FR=361.1",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":80},"St Louis","Missouri","63110","United States",[71,76],{"name":72,"role":73,"phone":74,"email":75},"Jayashree Rajamanickam","CONTACT","314-273-6140","jayashree.r@wustl.edu",{"name":77,"role":73,"phone":78,"email":79},"Kelley Jackson","314 362 3613","kelleyj@wustl.edu",{"lat":81,"lon":82},38.62727,-90.19789,[84,86],{"name":72,"role":73,"phone":85,"email":75},"314 273 6140",{"name":77,"role":73,"phone":78,"email":79},[88],{"name":89,"affiliation":12,"role":90},"Tammie Benzinger","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Alzheimer's Disease",[],{"nct_id":4,"found":14,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study comparing brain imaging results between healthy older adults and those with Alzheimer's disease and related dementias. It plans to enroll 80 participants.","completed","Investigation of Inflammation in Alzheimer's Disease Using [11C]-CS1P1","This study is looking into brain inflammation in Alzheimer's disease and related dementias (ADRD). Researchers will use a special imaging technique called a PET scan with a new, investigational radioactive tracer called [11C]-CS1P1. This tracer helps them see inflammation in the brain. The study aims to compare how [11C]-CS1P1 is taken up in the brains of healthy older adults versus those with mild cognitive impairment or early dementia due to ADRD. The goal is to see if [11C]-CS1P1 uptake is higher in people with ADRD, which could help us understand the disease better. The study plans to enroll 80 participants and is currently recruiting.","The primary imaging measurements will be taken through study completion, which is an average of 1 year.",104,"Participants will receive a single intravenous (into a vein) injection of [11C]-CS1P1 and then undergo a brain PET scan.","Not stated in the trial record.",[29],"v2"]