[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychosis-associated-with-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychosis-associated-with-alzheimers-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,59,99,120,143],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100525783","phase-3-a-study-to-assess-efficacy-and-safety-of-karxt-for-the-treatment-of-psychosis-associated-with-alzheimers-disease-adept-2-100525783",false,"NCT06126224","A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease","Key Inclusion Criteria:\n\n1. Is a male or female aged 55 to 90 years, inclusive, at Screening.\n2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.\n3. Meets clinical criteria for Possible AD or Probable AD.\n4. Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.\n5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.\n6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).\n7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.\n8. CGI-S scale with a score ≥ 4 at Screening and Baseline.\n9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:\n\n   1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR\n   2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items\n10. MMSE score of 8 to 22, inclusive, at Screening.\n\nKey Exclusion Criteria:\n\n1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n2. History of major depressive episode with psychotic features during the 12 months prior to Screening.\n3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.\n5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n6. Prior exposure to KarXT.\n7. History of hypersensitivity to KarXT excipients or trospium chloride.\n8. Experienced any significant adverse events (AEs) due to trospium.\n9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.\n10. Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","55 Years","90 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.\n\nThe primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.",[27],"Psychosis Associated With Alzheimer's Disease","RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-16","ACTUAL",{"date":34,"type":32},"2023-08-28",{"date":36,"type":21},"2026-12-09",{"name":38,"class":39},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","INDUSTRY",154,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":58},"100514626","phase-3-open-label-extension-study-to-assess-the-long-term-safety-and-tolerability-of-karxt-in-subjects-with-psychosis-associated-with-alzheimers-disease-adept-3-100514626","NCT05980949","Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)","Inclusion Criteria:\n\n* Must have completed study CN012-0026, CN012-0027 or CN012-0056.\n* Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.\n* Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.\n* At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor\u002FMedical Monitor must approve the subject's participation in the study.\n* Have an identified or proxy caregiver (spends approximately 10 hours\u002Fweek with the subject).\n\nExclusion Criteria:\n\n* Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.\n* Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.\n* Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":48,"type":21},800,[24],"This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.",[27],{"date":31,"type":32},{"date":54,"type":32},"2023-07-11",{"date":56,"type":21},"2027-09-07",{"name":38,"class":39},428,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100584273","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ml-007c-ma-for-the-treatment-of-alzheimers-disease-psychosis-100584273","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).",{"count":67,"type":21},300,[69],"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],[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"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","2026-05-15",{"date":91,"type":32},"2026-05-19",{"date":93,"type":32},"2025-08-15",{"date":95,"type":21},"2027-12",{"name":97,"class":39},"MapLight Therapeutics",40,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100478545","phase-3-a-study-to-assess-efficacy-and-safety-of-karxt-for-the-treatment-of-psychosis-associated-with-alzheimers-disease-adept-1-100478545","NCT05511363","A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n* Is aged 55 to 90 years, inclusive, at Screening\n* Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.\n\n  i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent.\n* Meets clinical criteria for possible or probable Alzheimer's Disease\n* Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.\n* Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.\n* Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥10 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:\n\n  i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study.\n* History of psychotic symptoms (meeting International Psychogeriatric Association \\[IPA\\] criteria) for at least 2 months prior to Screening.\n* Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.\n* Subjects are required to meet at least one of the following criteria at Screening and Baseline:\n\n  i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR; ii) Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.\n* Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening\n* If the subject is taking a cholinesterase inhibitor and\u002For memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.\n* Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements\n* BMI must be within 16 to 40 kg\u002Fm2 inclusive\n* Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP or matching placebo.\n\nExclusion Criteria:\n\n* Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia\n* History of major depressive episode with psychotic features during the 12 months prior to Screening\n* History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder\n* Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results\n* Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \\\u003C50 mL\u002Fmin\n* History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke\n* History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope\n* Any of the following:\n\n  i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes; vi) Implantable cardiac defibrillator.\n* Myocardial infarction within the 6 months prior to Screening\n* Personal or family history of symptoms of long QT syndrome as evaluated by the investigator\n* Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and\u002For active hepatic viral infections as indicated by medical history or liver function tests results\n* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator\n* Participants with any of the following:\n\n  i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:\n  1. Serum prostate specific antigen (PSA) \\> 10 ng\u002FmL at Screening\n  2. An IPSS of 5 (almost always) on items 1, 3, 5, or 6\n  3. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9\n* History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months\n* Risk of suicidal behavior during the study as determined by clinical assessment and\u002F or C-SSRS\n* Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening\n* Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor\n* Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam) and unable to complete the washout:\n\n  i) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening may be permitted; ii) Mirtazapine or trazodone may be used if started at least 8 weeks prior to Screening. If needed, an extension (up to two weeks) of the Screening Period may be allowed with approval of the Sponsor\u002FMedical Monitor.\n* If, in the opinion of the Investigator and\u002For Sponsor\u002FMedical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and\u002For Sponsor\u002F Medical Monitor, may compromise the safety of the subject or affect his\u002Fher ability to adhere to the protocol visit schedule or fulfill visit requirements\n* Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator\n* Unable to taper and discontinue a concomitant medication that would preclude participation in the study\n* Prior exposure to KarXT\n* Experienced any significant adverse events due to trospium, including a known hypersensitivity to trospium\n* Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the past year\n* Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":107,"type":21},410,[24],"This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.\n\nThe primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.",[27],"2026-04-30",{"date":113,"type":32},"2026-05-04",{"date":115,"type":32},"2022-08-23",{"date":117,"type":21},"2026-10-05",{"name":38,"class":39},116,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"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":129,"type":21},210,[69],"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],[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"2026-04-09",{"date":136,"type":32},"2026-04-14",{"date":138,"type":32},"2026-03-25",{"date":140,"type":21},"2029-03",{"name":97,"class":39},3,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100557647","phase-2-a-study-to-assess-the-efficacy-and-safety-of-iti-1284-in-the-treatment-of-psychosis-associated-with-alzheimers-disease-100557647","NCT06540833","A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n1. Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations;\n2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:\n\n   1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or\n   2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;\n4. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and\u002For Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;\n5. CGI-S score ≥ 4 at Screening and Baseline;\n6. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;\n7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);\n\nExclusion Criteria:\n\n1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:\n\n   1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n   2. Bipolar disorder;\n2. Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and\u002For as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening;\n3. The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee,\n4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia\n5. The patient is bedridden or has any significant medical condition that is unstable and would either:\n\n   1. Place the patient at undue risk from study drug or undergoing study procedures; or\n   2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;\n6. The patient is in hospice or end-of-life care;",{"count":151,"type":21},370,[69],"This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.",[27],"2026-01-12",{"date":157,"type":32},"2026-01-13",{"date":159,"type":32},"2024-08-15",{"date":161,"type":21},"2027-10",{"name":163,"class":39},"Intra-Cellular Therapies, Inc.",65]