A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
NCT ID: NCT06651567
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2024-10-22
2027-11-30
Brief Summary
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Detailed Description
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* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
* 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;
* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Interventions
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ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Eligibility Criteria
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Inclusion Criteria
* 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:
* Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or
* Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
* CGI-S score ≥ 4 at Screening and Baseline;
* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;
Exclusion Criteria
* Has been diagnosed with one or more of the following psychiatric conditions:
* Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
* Bipolar disorder;
* Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
* 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;
* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.
55 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Anaheim, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Boca Raton, Florida, United States
Clinical Site
Bonita Springs, Florida, United States
Clinical Site
Brandon, Florida, United States
Clinical Site
Delray Beach, Florida, United States
Clinical Site
Doral, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Homestead, Florida, United States
Clinical Site_2
Maitland, Florida, United States
Clinical Site
Maitland, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site_2
Miami, Florida, United States
Clinical Site_3
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site_2
Tampa, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
West Palm Beach, Florida, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Las Vegas, Nevada, United States
Clinical Site
Toms River, New Jersey, United States
Clinical Site
Raleigh, North Carolina, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
Lovech, , Bulgaria
Clinical Site
Pleven, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Stara Zagora, , Bulgaria
Clinical Site_2
Zagreb, , Croatia
Clinical Site_3
Zagreb, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Brno, , Czechia
Clinical Site
Choceň, , Czechia
Clinical Site
Kutná Hora, , Czechia
Clinical Site
Pilsen, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Sânpetru, , Romania
Clinical Site
Sibiu, , Romania
Clinical Site_2
Belgrade, , Serbia
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Niš, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Clinical Site
Banská Bystrica, , Slovakia
Clinical Site
Bratislava, , Slovakia
Clinical Site
Košice, , Slovakia
Clinical Site
Krompachy, , Slovakia
Clinical Site
Svidník, , Slovakia
Clinical Site
Vranov nad Topľou, , Slovakia
Clinical Site
Albacete, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Málaga, , Spain
Clinical Site
Zamora, , Spain
Clinical Site
Zaragoza, , Spain
Countries
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Central Contacts
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Other Identifiers
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ITI-1284-101
Identifier Type: -
Identifier Source: org_study_id
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