[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MapLight Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,84],{"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":25,"conditions":26,"keywords":28,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100584273","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psychosis-100584273",false,"NCT06887192","A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis","A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis","Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:\n\n   1. The participant's LAR must provide written informed consent AND\n   2. The participant will provide informed assent.\n2. Meets clinical criteria for Possible AD or Probable AD.\n3. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.\n4. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.\n5. Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.\n6. Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:\n\n   1. Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR\n   2. Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.\n7. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4\n8. Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.\n\nKey Exclusion Criteria:\n\n1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.\n2. Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.\n3. Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.\n4. Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.\n5. Has an elevated risk of suicidal behavior\n6. Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.\n7. Evidence of a clinically significant and\u002For unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.\n8. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma\n9. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).\n10. Has previously participated in any clinical study with ML-007 or ML-007C-MA.\n11. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.\n12. Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).","ALL","55 Years","90 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).\n\nThe primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.",[27],"Psychosis Associated With Alzheimer's Disease",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Alzheimer Disease","Brain Diseases","Central Nervous System Diseases","Delusions","Dementia","Hallucinations","Mental Disorders","Nervous System Diseases","Neurocognitive Disorders","Neurodegenerative Diseases","Psychotic Disorders","Schizophrenia Spectrum and Other Psychotic Disorders","Tauopathies","Muscarinic Antagonists","Muscarinic Agonists","Cholinergic Agents","RECRUITING","2026-05-15",{"date":48,"type":49},"2026-05-19","ACTUAL",{"date":51,"type":49},"2025-08-15",{"date":53,"type":21},"2027-12",{"name":55,"class":56},"MapLight Therapeutics","INDUSTRY",40,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100628285","phase-2-a-long-term-open-label-study-of-ml-007c-ma-in-adults-with-schizophrenia-100628285","NCT07459647","A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia","An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia","Key Inclusion Criteria:\n\n1. Must be able and willing to provide informed consent for all required study procedures.\n2. Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).\n3. May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.\n4. Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.\n5. Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \\>1 year.\n\nKey Exclusion Criteria:\n\n1. Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.\n2. Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.\n3. Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.\n4. Has current evidence of a clinically significant and\u002For unstable medical comorbidity at Screening or Baseline.\n5. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.\n6. Has an elevated risk of suicidal behavior.\n7. Has a known allergy to ML-007C-MA, its active ingredients or their excipients.\n8. Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening).\n9. Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.","18 Years","65 Years",{"count":68,"type":21},500,[24],"ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).",[72],"Schizophrenia",[74,35,39,72,42,43,44,36,31,30],"Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders","2026-04-17",{"date":77,"type":49},"2026-04-22",{"date":79,"type":49},"2026-03-31",{"date":81,"type":21},"2030-02",{"name":55,"class":56},5,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":5},"100628286","phase-2-an-open-label-study-of-ml-007c-ma-in-adults-with-alzheimers-disease-psychosis-100628286","NCT07459660","An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis","An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis","Inclusion Criteria\n\n1. Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:\n\n   1. The participant's LAR must provide written informed consent. AND\n   2. The participant will provide informed assent.\n2. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).\n3. May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.\n4. Has a designated study care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.\n5. Resides in a stable living environment (eg, home, residential assisted living, or nursing home facility) and is expected to remain in the living situation throughout the study.\n\nExclusion Criteria\n\n1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.\n2. Requires treatment with protocol-defined prohibited medications.\n3. Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and\u002For medical monitor, would compromise participant safety, interfere with the participant's ability to comply with study procedures, would preclude obtaining voluntary consent\u002Fassent, and\u002For would substantially impair the evaluation of study assessments.\n4. Has or had a clinically significant abnormal physical examination, vital sign, ECG or clinical laboratory safety result during or since the antecedent study that would compromise participant safety, interfere with the participant's ability to comply with study procedures, and\u002For would confound the interpretation of the outcome measures in the study in the opinion of the investigator.\n5. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.\n6. Has an elevated risk of suicidal behavior.","91 Years",{"count":93,"type":21},210,[24],"ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).",[27],[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"2026-04-09",{"date":100,"type":49},"2026-04-14",{"date":102,"type":49},"2026-03-25",{"date":104,"type":21},"2029-03",{"name":55,"class":56},""]