[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimers-disease-psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimers-disease-psychosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100528354","phase-2-acp-204-in-adults-with-alzheimers-disease-psychosis-100528354",false,"NCT06159673","ACP-204 in Adults With Alzheimer's Disease Psychosis","A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis","Inclusion Criteria:\n\n* Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting\n* Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)\n* Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD\n* Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD\n* Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association\n* MMSE score ≥6 and ≤24\n* Psychotic symptoms for at least 2 months\n* Lives in a stable place of residence and there are no plans to change living arrangements\n* Has a designated study partner\u002Fcaregiver\n* Able to complete all study visits with a study partner\u002Fcaregiver\n* Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable\n\nExclusion Criteria:\n\n* Requires treatment with a medication prohibited by the protocol\n* Is in hospice and receiving end-of-life palliative care, or has become bedridden\n* Requires skilled nursing care\n* Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia\n* Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope\n* Atrial fibrillation\n* Symptomatic orthostatic hypotension\n* Protocol-defined exclusionary clinical laboratory findings\n* Treatment with anti-tau therapy or donanemab within 2 months prior to Screening\n\nAdditional inclusion\u002Fexclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.","ALL","55 Years","95 Years",{"count":20,"type":21},1074,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP\n\n* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.\n* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.\n\nAll 3 substudies will be analyzed independently of each other.\n\nEach substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).",[28],"Alzheimer's Disease Psychosis",[30,31,32],"Alzheimer's disease psychosis","Hallucinations","Delusions","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2023-11-14",{"date":41,"type":21},"2028-02",{"name":43,"class":44},"ACADIA Pharmaceuticals Inc.","INDUSTRY",145,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100610674","phase-1-a-phase-1-mad-study-to-evaluate-the-safety-and-tolerability-of-ly03020-100610674","NCT07230652","A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020","A Randomized, Double-Blind, Placebo-Controlled, Dose- Ascending Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Chinese Adult Healthy Subjects and\u002For Subjects With Stable Schizophrenia","Inclusion Criteria:\n\nHealthy Subjects\n\n* Subjects sign informed consent voluntarily.\n* Male or female aged 18 to 45 years.\n* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg\u002Fm2 Subjects with Stable Schizophrenia\n* Subjects themselves and \u002F or their guardians sign informed consent voluntarily.\n* Male or female aged 18 to 60 years.\n* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg\u002Fm2.\n* Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.\n\nExclusion Criteria:\n\nHealthy Subjects\n\n* Subjects have any clinically significant medical condition or chronic disease.\n* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with a history of orthostatic hypotension or syncope.\n* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.\n* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.\n* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.\n* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation\n* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody. Subjects with Stable Schizophrenia\n* According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.\n* Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;\n* History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses (\"yes\") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening\u002Fbaseline;\n* Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements\u002Ftraditional Chinese herbal products within 7 days prior to first dosing.\n* Glycated hemoglobin (HbA1c) ≥7% at screening\u002Fbaseline.\n* Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate \\\u003C50 beats per minute (bpm) at screening\u002Fbaseline; or QTc \\>450 ms (male) \u002F QTc \\>460 ms (female) based on Fridericia's formula-corrected measurements at screening\u002Fbaseline.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with a history of orthostatic hypotension or syncope.",true,"18 Years","60 Years",{"count":57,"type":21},40,[59],"PHASE1","This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and\u002For subjects with stable schizophrenia.",[62,28],"Schizophrenia","2025-11-18",{"date":65,"type":37},"2025-11-19",{"date":67,"type":37},"2025-08-20",{"date":69,"type":21},"2026-02-28",{"name":71,"class":44},"Luye Pharma Group Ltd.",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100577107","phase-1-effect-of-food-and-age-on-the-pharmacokinetics-of-ly03017-100577107","NCT06793995","Effect of Food and Age on the Pharmacokinetics of LY03017","A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers","Inclusion Criteria:\n\n* Subject who voluntarily participate and sign the informed consent form.\n* Part A：Age ≥18 and ≤ 45 years, male and female.\n* Part B：Age ≥65 years, male and female.\n* Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and \\\u003C 28.0 kg\u002Fm2.\n* Able to comply with the lifestyle restrictions.\n\nExclusion Criteria:\n\n* Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.\n* Part A：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.\n* Part B：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.\n* Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.\n* Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as\n\n  1. Pulse \\\u003C 55 beats\u002Fmin or \\> 100 beats\u002Fmin,\n  2. Systolic blood pressure \\\u003C 90 mmHg or ≥140 mmHg, Diastolic blood pressure \\\u003C 60 mmHg or ≥90 mmHg,\n  3. QT interval (QTc) ≥450 ms.\n  4. Part B：aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin \\> 1.5 × upper limit normal (ULN), or estimated glomerular filtration rate（eGFR） \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* Part A：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.\n* Part B：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing, with the exception of concomitant drugs for the well-controlled, chronic and stable medical conditions.\n* Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.\n* Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).\n* Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.\n* Subject has a history of substance abuse within 1 year or a positive urine drug screen.\n* Subject who has daily smoking of ≥ 5 cigarettes within 3 months.\n* Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.\n* Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods\u002Fdrinks) within 48 hours prior to dosing and\u002For subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.\n* Subject who has participated in other clinical trials within 3 months before administration.\n* Subject has used blood products or being blood donor or blood loss within 3 months.\n* Pregnant, lactating women, or positive pregnancy test.\n* Subject who refusal to contraception, or plan to donate sperm or ovums.\n* Subject who has a history of needle or blood faintness.\n* Subject directly involved in this clinical trial.\n* Poor compliance or other conditions which would make participation in the study unsuitable.",{"count":81,"type":21},26,[59],"This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.",[28,85,86],"Parkinson Disease Psychosis","Negative Symptoms of Schizophrenia","NOT_YET_RECRUITING","2025-01-20",{"date":90,"type":37},"2025-01-27",{"date":92,"type":21},"2025-02",{"date":94,"type":21},"2025-10-31",{"name":71,"class":44}]