[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07095465":3,"trial-entities:NCT07095465":293,"trial-summary:NCT07095465":296},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":65,"locations":68,"central_contacts":289,"overall_officials":290,"references":291,"see_also_links":292},"NCT07095465","ACP-204-013","Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis","52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)","ENROLLING_BY_INVITATION","2029-03","2025-07","2026-07-24","2025-11-14","ACADIA Pharmaceuticals Inc.","INDUSTRY",true,"A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)","Study Website: https:\u002F\u002Fillumerastudy.com\u002F",[19],"Lewy Body Dementia Psychosis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},126,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","ACP-204","Provided as 1 capsule, to be taken orally once daily",[31],[35],"ACP-204 Tartrate",[37],{"measure":38,"timeFrame":39},"Proportion of subjects who experience treatment-emergent adverse events (TEAEs)","52 weeks",[],"ALL","55 Years","84 Years",false,{"inclusion":46,"exclusion":55,"raw_text":64},[47,48,49,50,51,52,53,54],"The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator","Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study","Can complete all study visits with a study partner\u002Fcaregiver","Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:","If the subject is a female, she must be of nonchildbearing potential","If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:","Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR","Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method",[56,57,58,59,60,61,62,63],"Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason","Is in hospice, is receiving end-of-life palliative care, or is bedridden","Has a heart rate \\\u003C50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.","Has a BMI \\\u003C18.5 kg\u002Fm2 or known unintentional weight loss ≥7% of body weight over past 6 months","Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:","Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)","Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study","Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction","Inclusion Criteria:\n\n* The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator\n* Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study\n* Can complete all study visits with a study partner\u002Fcaregiver\n* Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:\n\n  1. The subject's LAR (or study partner\u002Fcaregiver, if local regulations allow) must provide written informed consent.\n  2. The subject must provide written (if capable) informed assent per local regulations\n* If the subject is a female, she must be of nonchildbearing potential\n* If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:\n\n  1. Refrain from donating sperm, AND\n  2. Either\n\n     * Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n     * Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method\n\nExclusion Criteria:\n\n* Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason\n* Is in hospice, is receiving end-of-life palliative care, or is bedridden\n* Has a heart rate \\\u003C50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.\n* Has a BMI \\\u003C18.5 kg\u002Fm2 or known unintentional weight loss ≥7% of body weight over past 6 months\n* Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:\n\n  1. jeopardize the safe participation of the subject in this study; OR\n  2. interfere with the conduct or interpretation of safety or efficacy evaluations in the study\n* Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)\n* Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study\n* Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction",[66,67],"ADULT","OLDER_ADULT",[69,78,86,93,100,107,111,115,122,130,138,146,154,162,170,177,185,193,201,208,215,223,230,237,246,254,261,270,277,281],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"ATP Clinical Research Inc.","Irvine","California","92612","United States",{"lat":76,"lon":77},33.66946,-117.82311,{"facility":79,"city":80,"state":81,"zip":82,"country":74,"geoPoint":83},"Humanity Clinical Research, Corp","Aventura","Florida","33180",{"lat":84,"lon":85},25.95648,-80.13921,{"facility":87,"city":88,"state":81,"zip":89,"country":74,"geoPoint":90},"Parkinson's Disease and Movement Disorders Center of Boca Raton","Boca Raton","33486",{"lat":91,"lon":92},26.35869,-80.0831,{"facility":94,"city":95,"state":81,"zip":96,"country":74,"geoPoint":97},"K2 Summit Research","Lady Lake","32159",{"lat":98,"lon":99},28.91749,-81.92286,{"facility":101,"city":102,"state":81,"zip":103,"country":74,"geoPoint":104},"Homestead Associates in Research Inc","Miami","33032",{"lat":105,"lon":106},25.77427,-80.19366,{"facility":108,"city":102,"state":81,"zip":109,"country":74,"geoPoint":110},"Advanced Clinical Research Network, Corp","33135",{"lat":105,"lon":106},{"facility":112,"city":102,"state":81,"zip":113,"country":74,"geoPoint":114},"MediClear Medical & Research Center, Inc.","33165",{"lat":105,"lon":106},{"facility":116,"city":117,"state":81,"zip":118,"country":74,"geoPoint":119},"Health Synergy Clinical Research, LLC","West Palm Beach","33407",{"lat":120,"lon":121},26.71534,-80.05337,{"facility":123,"city":124,"state":125,"zip":126,"country":74,"geoPoint":127},"Hawaii Pacific Neuroscience","Honolulu","Hawaii","96817",{"lat":128,"lon":129},21.30694,-157.85833,{"facility":131,"city":132,"state":133,"zip":134,"country":74,"geoPoint":135},"University of Kansas Medical Center Research Institute Inc.","Kansas City","Kansas","66160",{"lat":136,"lon":137},39.11417,-94.62746,{"facility":139,"city":140,"state":141,"zip":142,"country":74,"geoPoint":143},"Parkinson's Disease and Movement Disorders Center of Boca Raton d\u002Fb\u002Fa Parkinson's Research Center of America-Long Island","Commack","New York","11725",{"lat":144,"lon":145},40.84288,-73.29289,{"facility":147,"city":148,"state":149,"zip":150,"country":74,"geoPoint":151},"The Ohio State University, Energy Advancement and Innovation Center","Columbus","Ohio","43210",{"lat":152,"lon":153},39.96118,-82.99879,{"facility":155,"city":156,"state":157,"zip":158,"country":74,"geoPoint":159},"The Movement Disorder Clinic of Oklahoma","Tulsa","Oklahoma","74136",{"lat":160,"lon":161},36.15398,-95.99277,{"facility":163,"city":164,"state":165,"zip":166,"country":74,"geoPoint":167},"Horizon Clinical Research Group","Cypress","Texas","77429",{"lat":168,"lon":169},29.96911,-95.69717,{"facility":171,"city":172,"state":165,"zip":173,"country":74,"geoPoint":174},"R and H Clinical Research","Stafford","77477",{"lat":175,"lon":176},29.61607,-95.55772,{"facility":178,"city":179,"state":180,"zip":181,"country":74,"geoPoint":182},"Virginia Commonwealth University (a public institution of higher education)","Richmond","Virginia","23219",{"lat":183,"lon":184},37.55376,-77.46026,{"facility":186,"city":187,"state":188,"zip":189,"country":74,"geoPoint":190},"EvergreenHealth","Kirkland","Washington","98034",{"lat":191,"lon":192},47.68149,-122.20874,{"facility":194,"city":195,"zip":196,"country":197,"geoPoint":198},"Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov","Cherven Bryag","5980","Bulgaria",{"lat":199,"lon":200},43.27884,24.08251,{"facility":202,"city":203,"zip":204,"country":197,"geoPoint":205},"DCC \"Sv. Vrach and Sv. Sv. Kuzma and Damyan\", OOD","Sofia","1408",{"lat":206,"lon":207},42.69751,23.32415,{"facility":209,"city":210,"zip":211,"country":197,"geoPoint":212},"DCC Mladost M- Varna, OOD","Varna","9000",{"lat":213,"lon":214},43.21912,27.91024,{"facility":216,"city":217,"zip":218,"country":219,"geoPoint":220},"Fakultni Nemocnice u sv. Anny v Brne","Brno","656 91","Czechia",{"lat":221,"lon":222},49.19522,16.60796,{"facility":224,"city":225,"zip":226,"country":219,"geoPoint":227},"NEUROHK s.r.o. Poliklinika Chocen a.s.","Choceň","56501",{"lat":228,"lon":229},50.00161,16.22303,{"facility":231,"city":232,"zip":233,"country":219,"geoPoint":234},"Vestra Clinics s.r.o","Rychnov nad Kněžnou","51601",{"lat":235,"lon":236},50.16284,16.27488,{"facility":238,"city":239,"state":240,"zip":241,"country":242,"geoPoint":243},"CHU Tours- Hopital Bretonneau","Tours","Cedex 9","37044","France",{"lat":244,"lon":245},47.39484,0.70398,{"facility":247,"city":248,"state":249,"zip":250,"country":242,"geoPoint":251},"Hopital Neurologique Bron","Bron","Rhone","69677",{"lat":252,"lon":253},45.73865,4.91303,{"facility":255,"city":256,"zip":257,"country":242,"geoPoint":258},"CHU Strasbourg-Hopital Hautepierre","Strasbourg","67000",{"lat":259,"lon":260},48.58392,7.74553,{"facility":262,"city":263,"state":264,"zip":265,"country":266,"geoPoint":267},"Azienda Ospedaliera Univerrsitaria","Naples","Napoli","80138","Italy",{"lat":268,"lon":269},40.85216,14.26811,{"facility":271,"city":272,"state":272,"zip":273,"country":266,"geoPoint":274},"Università Campus Bio-Medico di Roma","Roma","128",{"lat":275,"lon":276},44.99364,11.10642,{"facility":278,"city":272,"state":272,"zip":279,"country":266,"geoPoint":280},"Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia","185",{"lat":275,"lon":276},{"facility":282,"city":283,"zip":284,"country":285,"geoPoint":286},"Institute of Mental Health","Belgrade","11000","Serbia",{"lat":287,"lon":288},44.80401,20.46513,[],[],[],[],{"nct_id":4,"conditions":294,"biomarkers":295},[19],[],{"nct_id":4,"found":44,"summary":297,"prompt_version":297},null]