Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT06887192
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003702', 'term': 'Delusions'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D006212', 'term': 'Hallucinations'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score', 'timeFrame': 'Baseline and End of Treatment (7 weeks)', 'description': 'NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score', 'timeFrame': 'Baseline and End of Treatment (7 weeks)', 'description': "The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes."}, {'measure': 'Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline', 'timeFrame': 'Baseline and End of Treatment (7 weeks)', 'description': 'NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['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'], 'conditions': ["Psychosis Associated With Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 (or care partner, if local regulations allow) must provide written informed consent AND\n 2. The participant will provide written (if capable) informed assent.\n2. Aged 55 to 90 years, inclusive, at time of informed consent.\n3. Meets clinical criteria for Possible AD or Probable AD.\n4. Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.\n5. Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.\n6. 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.\n7. 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.\n8. Has a (CGI)-S hallucinations and delusions domain-specific score ≥4\n9. 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 had an amyloid positron emission tomography (PET) brain scan or cerebrospinal fluid (CSF) Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.\n6. Evidence of a clinically significant and/or 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.\n7. Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma\n8. Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).\n9. Has previously participated in any clinical study with ML-007 or ML-007C-MA.\n10. 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)."}, 'identificationModule': {'nctId': 'NCT06887192', 'briefTitle': "A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis", 'organization': {'class': 'INDUSTRY', 'fullName': 'MapLight Therapeutics'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'ML-007C-MA-221'}, 'secondaryIdInfos': [{'id': '2024-519820-26-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ML-007C-MA', 'interventionNames': ['Drug: ML-007C-MA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ML-007C-MA', 'type': 'DRUG', 'description': 'ML-007C-MA dosed as 105/1.5 mg (one tablet of 105/1.5 mg ML-007C-MA), or 210/3 mg (two tablets of 105/1.5 mg ML-007C-MA )', 'armGroupLabels': ['ML-007C-MA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85253', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92866', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33442', 'city': 'Deerfield Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33033', 'city': 'Homestead', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'zip': '33104', 'city': 'Miami Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'zip': '34105', 'city': 'Naples', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32807', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '44131', 'city': 'Independence', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 41.36866, 'lon': -81.6379}}, {'zip': 'L6W 2Z8', 'city': 'Brampton', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Clinical Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Clinical Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Clinical Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G6V 0C9', 'city': 'Lévis', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Clinical Site', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}], 'centralContacts': [{'name': 'Clinical Trials Contact Center', 'role': 'CONTACT', 'email': 'ML-007C-MA-ADP@maplightrx.com', 'phone': '+1 650 839 4380'}], 'overallOfficials': [{'name': 'MapLight Therapeutics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MapLight Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MapLight Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}