[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-psychosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,66,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100502628","phase-2-clinical-trial-evaluating-the-efficacy-and-safety-of-agb101-for-treatment-of-parkinsons-disease-related-psychosis-100502628",false,"NCT05824728","Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis","AGB101 PDP","Subjects must meet all of the following inclusion criteria at screening:\n\n1. Subjects between 40 and 85 years old (inclusive) in good general health:\n\n   1. Willing and able to consent and participate for the duration of the study.\n   2. Have eighth-grade education or good work history sufficient to exclude mental retardation.\n   3. Have visual and auditory acuity adequate for neuropsychological testing.\n   4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments.\n2. Have a study partner who has sufficient contact (≥ 2 hours per week) with the subject to assist with dosing of study medication (if necessary) and provide assessments of any changes and an independent evaluation of the subject's functioning.\n3. Have PDP as defined by all of the following criteria and consistent with the National Institute of Neurological Disorders and Stroke\u002FNational Institute of Mental Health (NINDS\u002FNIMH) criteria:\n\n   1. Meets United Kingdom brain bank criteria for PD\n   2. Presence of at least one of the following symptoms\n\n      * Illusions\n      * False sense of presence\n      * Hallucinations\n      * Delusions\n   3. The symptoms of Criterion b occur after the onset of PD.\n   4. The symptoms of Criterion b are recurrent or continuous for 1 month.\n   5. The symptoms of Criterion b are not better accounted for by another cause of Parkinsonism such as dementia with Lewy bodies, psychiatric disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, or a general medical condition including delirium.\n   6. May have the following associated features:\n\n      * With\u002Fwithout insight\n      * With\u002Fwithout dementia\n      * With\u002Fwithout treatment for PD\n4. Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit.\n5. Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization.\n6. Patients must be on a stable regimen of medication for PD for at least 4 weeks prior to randomization.\n7. Permitted medications:\n\n   1. With potential pro-cognitive effects, such as cholinesterase inhibitors, memantine, estrogen replacement therapy, must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study\n   2. Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.\n   3. Antipsychotics must be must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.\n8. Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI.\n9. Participant and partner must both be willing to use an effective contraception for duration of the study and for 4 days after it. For women, effective contraception may be hormonal; for men, a condom.\n\nExclusion Criteria:\n\nSubjects must not meet any of the following exclusion criteria at screening:\n\n1. Use of anticonvulsant medications within 1 month prior to the baseline visit.\n2. Participation in a therapeutic clinical study for any medical or psychiatric indications within 1 month of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose\u002Fadministration was received within 1 month prior to screening.\n3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).\n4. Severe renal impairment (creatinine clearance of \\\u003C 30 mL\u002Fminute) or undergoing hemodialysis.\n5. Delirium due to the presence of an acute metabolic encephalopathy secondary to infection or from any other cause as assessed by the investigator based on labs, history, and physical exam.\n6. Neurological disorder other than Parkinson's disease, such as Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, that in the opinion of the investigator might interfere with the conduct of the study.\n7. Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis.\n8. Stereotactic surgery for deep brain stimulation (DBS), presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI scan.\n9. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).\n10. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.\n11. Any unstable medical condition that is likely to require new medical or surgical treatment during the course of the study and where such treatments might affect the collection of efficacy data.\n12. Unable or unwilling to provide informed consent or to comply with study procedures.\n13. Patient or caregiver unable to administer daily oral dosing of study drug.\n14. Current suicidal ideation.\n15. Female subjects must not be pregnant or lactating.\n16. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.","ALL","40 Years","85 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical\u002Fneurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.",[27],"Parkinson Disease Psychosis","RECRUITING","2025-10-13",{"date":31,"type":32},"2025-10-14","ACTUAL",{"date":34,"type":32},"2023-09-28",{"date":36,"type":21},"2026-09",{"name":38,"class":39},"Johns Hopkins University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100466736","phase-4-characterization-of-the-serotonin-2a-receptor-selective-pet-tracer-18fmhmz-in-patients-with-neurodegenerative-diseases-100466736","NCT05357612","Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases","Inclusion Criteria:\n\n* Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants\n* Healthy arm - age and gender matched to patient arm\n* Psychosis (presence of hallucinations or delusions) starting after the diagnosis of Parkinson's disease, occurring at least weekly for 4 weeks, severe enough to warrant treatment.\n* Study partner available for study visits\n\nExclusion Criteria:\n\n* Prior stroke or other uncontrolled serious neurological or medical illness\n* Contra-indication or inability to tolerate MRI scan\n* Use of serotonergic medications in the last 6 weeks\n* Incapable of providing independent consent.\n* Pregnant or breastfeeding women\n* psychosis due to a metabolic, toxic, or primary psychiatric disease\n* Deemed unable to complete neurocognitive testing\n* For PD Participants: current or prior use of pimavanserin\n* Use of antipsychotics in the last 2 weeks",true,"50 Years",{"count":50,"type":21},75,[52],"PHASE4","It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age\u002Fsex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\\[18F\\]MH.MZ in both populations.",[55,56,27],"Neurodegenerative Diseases","Parkinson Disease","2025-08-06",{"date":59,"type":32},"2025-08-12",{"date":61,"type":32},"2023-01-23",{"date":63,"type":21},"2026-08",{"name":65,"class":39},"Vanderbilt University Medical Center",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":47,"sex":16,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":40},"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.","18 Years",{"count":75,"type":21},26,[77],"PHASE1","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.",[80,27,81],"Alzheimer's Disease Psychosis","Negative Symptoms of Schizophrenia","NOT_YET_RECRUITING","2025-01-20",{"date":85,"type":32},"2025-01-27",{"date":87,"type":21},"2025-02",{"date":89,"type":21},"2025-10-31",{"name":91,"class":92},"Luye Pharma Group Ltd.","INDUSTRY",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":47,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":40},"100515767","phase-1-a-phase-1-sad-and-mad-study-to-evaluate-the-safety-and-tolerability-of-fb418-100515767","NCT05995782","A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult Subjects and Healthy Elderly Subjects","Key Inclusion Criteria:\n\n1. Healthy, adult, male 19 55 years of age, inclusive, at the screening.\n2. For elderly subjects(Part A Cohort 5 only), healthy, elderly, male or female (of non childbearing potential only) over 60 years of age, inclusive, at screening.\n3. In the case of the elderly(Part A Cohort 5 only), they have a history of mild disease, but can participate if the researcher judges that they can stop taking the drug at least 2 weeks before the expected first dose or before the half-life is 5 times or more)\n4. The continuous non smoker who have not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study are based on subjective self reporting.\n5. Body mass index (BMI) ≥ 18 and ≤ 32 kg\u002Fm2 at the screening.\n6. Medically healthy with no clinically significant medical history, physical examination, simplified neurological examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.\n7. In Cohort 5, A female subject must be of non childbearing potential\n\nKey Exclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.\n4. Is at suicidal risk in the opinion of the PI as per the following criteria:\n\n   1. Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.\n   2. C-SSRS answer of \"YES\" on suicidal ideation within 3 months prior to screening.\n5. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing.\n6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.\n7. History of seizures (childhood febrile seizures are excepted).\n8. Positive urine drug or alcohol results at screening or check in.\n9. Has an abnormal screening ECG indicating a second- or third- degree AV block, or one or more of the following: QRS \\> 120 msec, QTcF \\> 450 msec for males and \\> 460 msec for females, PR interval \\> 220 msec. Any rhythm other than normal sinus rhythm, which is interpreted by the PI or designee to be clinically significant at screening or check-in.\n10. Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.","19 Years",{"count":102,"type":21},64,[77],"The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.",[27,106],"Amyotrophic Lateral Sclerosis (ALS)","2024-11-27",{"date":109,"type":32},"2024-12-02",{"date":111,"type":32},"2023-12-20",{"date":113,"type":21},"2024-12",{"name":115,"class":92},"1ST Biotherapeutics, Inc."]