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

NCT06651567 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ITI-1284-101
• Study Type: interventional
• Target: 320
• Locations: 8 countries
• Sites: 69

Brief 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

Conditions

Agitation Associated With Alzheimer's Dementia

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI) total score

  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.

  Week 12

Secondary Outcomes (1)

• Clinical Global Impression-Severity (CGI-S) Score

  Week 12

Study Arms (2)

ITI-1284

EXPERIMENTAL

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

Drug: ITI-1284

Placebo

PLACEBO COMPARATOR

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Drug: Placebo

Interventions

ITI-1284 DRUG

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

ITI-1284

Placebo DRUG

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (69)

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Costa Mesa, California, 92626, United States

RECRUITING

Clinical Site

Garden Grove, California, 92844, United States

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Clinical Site

Boca Raton, Florida, 33487, United States

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Clinical Site

Bonita Springs, Florida, 34134, United States

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Clinical Site

Brandon, Florida, 33511, United States

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Clinical Site

Delray Beach, Florida, 33445, United States

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Clinical Site

Doral, Florida, 33178, United States

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Clinical Site

Hialeah, Florida, 33012, United States

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Clinical Site

Homestead, Florida, 33033, United States

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Clinical Site_2

Maitland, Florida, 32751, United States

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Clinical Site

Maitland, Florida, 32751, United States

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Clinical Site

Miami, Florida, 33122, United States

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Clinical Site_2

Miami, Florida, 33135, United States

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Clinical Site_3

Miami, Florida, 33135, United States

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Clinical Site

Miami, Florida, 33135, United States

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Clinical Site

Miami, Florida, 33137, United States

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Clinical Site

Miami, Florida, 33155, United States

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Clinical Site

Miami, Florida, 33166, United States

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Clinical Site

Miami, Florida, 33186, United States

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Clinical Site

Orlando, Florida, 32803, United States

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Clinical Site

Orlando, Florida, 32807, United States

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Clinical Site_2

Tampa, Florida, 33614, United States

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Clinical Site

Tampa, Florida, 33614, United States

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Clinical Site

West Palm Beach, Florida, 33407, United States

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Clinical Site

Boston, Massachusetts, 02111, United States

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Clinical Site

Las Vegas, Nevada, 89121, United States

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Clinical Site

Toms River, New Jersey, 08755, United States

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Clinical Site

Raleigh, North Carolina, 27607, United States

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Clinical Site

San Antonio, Texas, 78229, United States

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Clinical Site

Lovech, 5500, Bulgaria

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Clinical Site

Pleven, 5800, Bulgaria

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Clinical Site

Sofia, 1377, Bulgaria

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Clinical Site

Sofia, 1408, Bulgaria

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Clinical Site

Sofia, 1510, Bulgaria

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Clinical Site

Sofia, 1680, Bulgaria

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Clinical Site

Stara Zagora, 6000, Bulgaria

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Clinical Site_2

Zagreb, 10000, Croatia

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Clinical Site_3

Zagreb, 10000, Croatia

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Clinical Site

Zagreb, 10000, Croatia

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Clinical Site

Zagreb, 10090, Croatia

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Clinical Site

Brno, 602 00, Czechia

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Clinical Site

Choceň, 56501, Czechia

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Clinical Site

Kutná Hora, 284 01, Czechia

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Clinical Site

Pilsen, 30100, Czechia

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Clinical Site

Prague, 100 00, Czechia

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Clinical Site

Prague, 160 00, Czechia

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Clinical Site

Bucharest, 010825, Romania

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Clinical Site

Bucharest, 040874, Romania

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Clinical Site

Bucharest, 041914, Romania

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Clinical Site

Bucharest, 060222, Romania

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Clinical Site

Sânpetru, 507190, Romania

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Clinical Site

Sibiu, 550281, Romania

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Clinical Site_2

Belgrade, 11000, Serbia

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Clinical Site

Belgrade, 11000, Serbia

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Clinical Site

Kovin, 26220, Serbia

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Clinical Site

Niš, 18000, Serbia

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Clinical Site

Novi Kneževac, 23330, Serbia

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Clinical Site

Banská Bystrica, 97404, Slovakia

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Clinical Site

Bratislava, 81369, Slovakia

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Clinical Site

Košice, 4001, Slovakia

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Clinical Site

Krompachy, 05342, Slovakia

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Clinical Site

Svidník, 08901, Slovakia

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Clinical Site

Vranov nad Topľou, 09301, Slovakia

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Clinical Site

Albacete, 02006, Spain

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Clinical Site

Barcelona, 08916, Spain

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Clinical Site

Málaga, 29004, Spain

RECRUITING

Clinical Site

Zamora, 49021, Spain

RECRUITING

Clinical Site

Zaragoza, 50012, Spain

RECRUITING

Central Study Contacts

ITI Clinical Trials

CONTACT

646-440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (7); RO (6); SL (6); CZ (6); US (30); SE (5); CR (4); ES (5)