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RECRUITING

NCT06651567

PHASE2

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2024-10-22

Completion Date

2027-11

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Agitation Associated With Alzheimer's Dementia

Interventions

DRUG

ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

DRUG

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Inclusion Criteria: * 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; * 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: * Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment; * 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.

Locations (69)

Clinical Site

Anaheim, California, United States

Clinical Site

Costa Mesa, California, United States

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Garden Grove, California, United States

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Boca Raton, Florida, United States

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Bonita Springs, Florida, United States

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Brandon, Florida, United States

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Delray Beach, Florida, United States

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Doral, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

Clinical Site_2

Maitland, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

Clinical Site_2

Miami, Florida, United States

Clinical Site_3

Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site_2

Tampa, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Boston, Massachusetts, United States

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Las Vegas, Nevada, United States

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Toms River, New Jersey, United States

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Raleigh, North Carolina, United States

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San Antonio, Texas, United States

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Lovech, Bulgaria

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Pleven, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

Clinical Site_2

Zagreb, Croatia

Clinical Site_3

Zagreb, Croatia

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Zagreb, Croatia

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Zagreb, Croatia

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Brno, Czechia

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Choceň, Czechia

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Kutná Hora, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Prague, Czechia

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Sânpetru, Romania

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Sibiu, Romania

Clinical Site_2

Belgrade, Serbia

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Belgrade, Serbia

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Kovin, Serbia

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Niš, Serbia

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Novi Kneževac, Serbia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Košice, Slovakia

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Krompachy, Slovakia

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Svidník, Slovakia

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Vranov nad Topľou, Slovakia

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Albacete, Spain

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Barcelona, Spain

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Málaga, Spain

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Zamora, Spain

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Zaragoza, Spain

Clinical Research Directory

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (69)