Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT06651567
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohen-Mansfield Agitation Inventory (CMAI) total score', 'timeFrame': 'Week 12', 'description': 'The CMAI is a reliable and validated, 29-item caregiver-rating questionnaire to assess agitated behavior in elderly patients. Each item is rated on a 7-point scale of frequency, from "never" (1) to "several times an hour" (7), with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression-Severity (CGI-S) Score', 'timeFrame': 'Week 12', 'description': "The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Agitation Associated With Alzheimer's Dementia"]}, 'descriptionModule': {'briefSummary': "This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia", 'detailedDescription': 'The study will be conducted in 3 periods:\n\n* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;\n* Double-blind Treatment Period (12 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo;\n* Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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;\n* Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:\n\n * Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or\n * Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition:\n* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;\n* CGI-S score ≥ 4 at Screening and Baseline;\n* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;\n\nExclusion Criteria:\n\n* Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;\n* Has been diagnosed with one or more of the following psychiatric conditions:\n\n * Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n * Bipolar disorder;\n * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;\n* Has a significant 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/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;\n* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients."}, 'identificationModule': {'nctId': 'NCT06651567', 'briefTitle': "A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia", 'organization': {'class': 'INDUSTRY', 'fullName': 'Intra-Cellular Therapies, Inc.'}, 'officialTitle': "A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia", 'orgStudyIdInfo': {'id': 'ITI-1284-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ITI-1284', 'description': 'ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration', 'interventionNames': ['Drug: ITI-1284']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo rapidly disintegrating tablet, taken once daily, sublingual administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ITI-1284', 'type': 'DRUG', 'description': 'ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration', 'armGroupLabels': ['ITI-1284']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo rapidly disintegrating tablet, taken once daily, sublingual administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34134', 'city': 'Bonita Springs', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.33981, 'lon': -81.7787}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33178', 'city': 'Doral', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33032', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_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': '33186', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}], 'centralContacts': [{'name': 'ITI Clinical Trials', 'role': 'CONTACT', 'email': 'ITCIClinicalTrials@itci-inc.com', 'phone': '646-440-9333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intra-Cellular Therapies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}