[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07598370":3,"trial-entities:NCT07598370":208,"trial-summary:NCT07598370":213},{"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":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":41,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":78,"locations":81,"central_contacts":194,"overall_officials":202,"references":206,"see_also_links":207},"NCT07598370","18818","A Study of LY3439539 in Participants With Alzheimer's Disease","A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease","RECRUITING","2027-08","2026-07","2026-07-20","2026-05-21","Eli Lilly and Company","INDUSTRY",false,"The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.\n\nParticipation in the study will last approximately 9 months with visits about once a month.",null,[19],"Alzheimer Disease",[21,22,23],"Cognitive Impairment","Neurodegenerative Diseases","Dementia","INTERVENTIONAL","BASIC_SCIENCE",[27],"PHASE1",{"count":29,"type":30},30,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","LY3439539","Administered IV",[34],[38],{"measure":39,"timeFrame":40},"Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)","Baseline through end of the Follow-up Period (Week 24)",[42,44,46,48],{"measure":43,"timeFrame":40},"Change from Baseline in Phospho-Tau (pTau)",{"measure":45,"timeFrame":40},"Change from Baseline in Plasma NfL",{"measure":47,"timeFrame":40},"Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)",{"measure":49,"timeFrame":50},"PK: Minimum LY3439539 Serum Concentration (Cmin)","Time Frame: Baseline through end of Follow up Period (Week 24)","ALL","50 Years","85 Years",{"inclusion":55,"exclusion":63,"raw_text":77},[56,57,58,59,60,61,62],"Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease","Have a Mini Mental Score Examination score of 16 to 24, inclusive","Meet plasma pTau criteria, as defined by the sponsor","Have body mass index within the range of 17 and 32 kilograms per square meter (kg\u002Fm²) (inclusive) at screening","Are women not of childbearing potential and men willing to practice effective contraception throughout the study.","Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.","Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).",[64,65,66,67,68,69,70,71,72,73,74,75,76],"Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants\u002Fcardiac pacemaker.","Have a screening MRI that shows evidence of significant abnormality.","Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.","Have a history of","Severe or ongoing allergy or hypersensitivity reactions","Hypersensitivity to immunizations or immunoglobulins","Two or more clinically significant or severe drug allergies,","Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions","Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions","Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.","Have criteria that would preclude a lumbar puncture (LP).","Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.","Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.","Inclusion Criteria:\n\n* Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease\n* Have a Mini Mental Score Examination score of 16 to 24, inclusive\n* Meet plasma pTau criteria, as defined by the sponsor\n* Have body mass index within the range of 17 and 32 kilograms per square meter (kg\u002Fm²) (inclusive) at screening\n* Are women not of childbearing potential and men willing to practice effective contraception throughout the study.\n* Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.\n* Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).\n\nExclusion Criteria:\n\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants\u002Fcardiac pacemaker.\n* Have a screening MRI that shows evidence of significant abnormality.\n* Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.\n* Have a history of\n\n  * Severe or ongoing allergy or hypersensitivity reactions\n  * Hypersensitivity to immunizations or immunoglobulins\n  * Two or more clinically significant or severe drug allergies,\n  * Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions\n* Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions\n* Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.\n* Have criteria that would preclude a lumbar puncture (LP).\n* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.",[79,80],"ADULT","OLDER_ADULT",[82,99,112,124,136,148,157,169,182],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":96},"Irvine Clinical Research","NOT_YET_RECRUITING","Irvine","California","92614","United States",[90,93],{"role":91,"phone":92},"CONTACT","949-753-1663",{"name":94,"role":95},"Elly Lee","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},33.66946,-117.82311,{"facility":100,"status":84,"city":101,"zip":102,"country":103,"contacts":104,"geoPoint":109},"Flinders Medical Centre","Adelaide","5042","Australia",[105,107],{"role":91,"phone":106},"+61 482 130 622",{"name":108,"role":95},"Lauren Priest",{"lat":110,"lon":111},-34.92866,138.59863,{"facility":113,"status":84,"city":114,"zip":115,"country":103,"contacts":116,"geoPoint":121},"University of the Sunshine Coast Clinical Trial Centre","Birtinya","4575",[117,119],{"role":91,"phone":118},"+617 54563872",{"name":120,"role":95},"Peter De Wet",{"lat":122,"lon":123},-26.74322,153.11913,{"facility":125,"status":8,"city":126,"zip":127,"country":103,"contacts":128,"geoPoint":133},"Austin Health - Heidelberg Repatriation Hospital","Ivanhoe","3079",[129,131],{"role":91,"phone":130},"+613 9496 2388",{"name":132,"role":95},"Paul Yates",{"lat":134,"lon":135},-37.76903,145.04308,{"facility":137,"status":8,"city":138,"zip":139,"country":103,"contacts":140,"geoPoint":145},"Southern Neurology","Kogarah","2217",[141,143],{"role":91,"phone":142},"+612 8566 1500",{"name":144,"role":95},"Raymond Schwartz",{"lat":146,"lon":147},-33.9681,151.13564,{"facility":149,"status":8,"city":150,"zip":151,"country":103,"contacts":152},"Macquarie University Hospital","Macquarie University","2109",[153,155],{"role":91,"phone":154},"0298122956",{"name":156,"role":95},"James Burrell",{"facility":158,"status":8,"city":159,"zip":160,"country":103,"contacts":161,"geoPoint":166},"The Alfred","Melbourne","3004",[162,164],{"role":91,"phone":163},"0437 498 365",{"name":165,"role":95},"David Darby",{"lat":167,"lon":168},-37.814,144.96332,{"facility":170,"status":84,"city":171,"zip":172,"country":173,"contacts":174,"geoPoint":179},"New Zealand Brain Research Institute","Christchurch","8011","New Zealand",[175,177],{"role":91,"phone":176},"+ 64 33786662",{"name":178,"role":95},"Timothy Anderson",{"lat":180,"lon":181},-43.53333,172.63333,{"facility":183,"status":8,"city":184,"zip":185,"country":184,"contacts":186,"geoPoint":191},"Lilly Centre for Clinical Pharmacology","Singapore","138623",[187,189],{"role":91,"phone":188},"+65 6413 9811",{"name":190,"role":95},"Jeffer Hann Wei Pang",{"lat":192,"lon":193},1.28967,103.85007,[195,199],{"name":196,"role":91,"phone":197,"email":198},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","LillyTrials@Lilly.com",{"name":200,"role":91,"email":201},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[203],{"name":204,"affiliation":13,"role":205},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":209,"biomarkers":211},[210],"Alzheimer's Disease",[212],"Microtubule-Associated Protein Tau",{"nct_id":4,"found":214,"summary":215,"prompt_version":225},true,{"design":216,"status":217,"heading":218,"summary":219,"follow_up":220,"word_count":221,"commitments":222,"compensation":223,"drugs_mentioned":224},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.","completed","A Study of LY3439539 for Alzheimer's Disease","This study is testing a drug called LY3439539, which is given through an IV (intravenous infusion). Researchers want to see how this drug affects specific proteins in the spinal fluid of people with Alzheimer's disease. LY3439539 is a monoclonal antibody, a type of protein that can target specific substances in the body. To join, you should be between 50 and 85 years old, have a diagnosis of Alzheimer's disease with memory changes for at least 6 months, and meet certain scores on a memory test (Mini Mental Score Examination of 16-24). You also need to meet specific plasma pTau criteria (a biomarker for Alzheimer's) and have a body mass index between 17 and 32. The main goal is to measure changes in a protein called Neurofilament Light Chain (NfL) in your spinal fluid over 24 weeks. The study plans to enroll 30 participants.","Changes in spinal fluid Neurofilament Light Chain (NfL) will be measured through the end of the Follow-up Period (Week 24).",143,"Participation in the study will last approximately 9 months, with visits about once a month.","Not stated in the trial record.",[34],"v2"]