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

NCT06540833 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ITI-1284-201
• Study Type: interventional
• Target: 370
• Locations: 9 countries
• Sites: 65

Brief Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Conditions

Psychosis Associated With Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• BEHAVE-AD psychosis subscale score

  The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36.

  Week 6

Secondary Outcomes (1)

• CGI-S score

  Week 6

Study Arms (2)

ITI-1284

EXPERIMENTAL

Drug: ITI-1284

Placebo

PLACEBO COMPARATOR

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 AD based on 2011 NIA-AA criteria and either:
• Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
• Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
• Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
• Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;
• CGI-S score ≥ 4 at Screening and Baseline;
• Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;
• Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

You may not qualify if:

• Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or 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;
• 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 C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee,
• The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
• The patient is bedridden or has any significant medical condition that is unstable and would either:
• Place the patient at undue risk from study drug or undergoing study procedures; or
• Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
• The patient is in hospice or end-of-life care;

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (65)

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Costa Mesa, California, 92626, United States

ACTIVE NOT RECRUITING

Clinical Site

Lafayette, California, 94549, United States

NOT YET RECRUITING

Clinical Site

Los Alamitos, California, 90720, United States

WITHDRAWN

Clinical Site

Newport Beach, California, 92660, United States

RECRUITING

Clinical Site

Orange, California, 92866, United States

RECRUITING

Clinical Site

Bonita Springs, Florida, 34134, United States

RECRUITING

Clinical Site

Brandon, Florida, 33511, United States

RECRUITING

Clinical Site

Coral Springs, Florida, 33067, United States

RECRUITING

Clinical Site

Delray Beach, Florida, 33445, United States

RECRUITING

Clinical Site

Doral, Florida, 33178, United States

RECRUITING

Clinical Site

Homestead, Florida, 33033, United States

RECRUITING

Clinical Site

Maitland, Florida, 32751, United States

RECRUITING

Clinical Site

Miami, Florida, 33135, United States

RECRUITING

Clinical Site

Miami, Florida, 33144, United States

RECRUITING

Clinical Site

Miami, Florida, 33155, United States

RECRUITING

Clinical Site

Miami, Florida, 33166, United States

RECRUITING

Clinical Site

Miami, Florida, 33186, United States

RECRUITING

Clinical Site

Orlando, Florida, 32803, United States

RECRUITING

Clinical Site

Sarasota, Florida, 34239, United States

RECRUITING

Clinical Site

Tampa, Florida, 33613, United States

RECRUITING

Clinical Site

Tampa, Florida, 33614, United States

RECRUITING

Clinical Site

Toms River, New Jersey, 08755, United States

RECRUITING

Clinical Site

Charlotte, North Carolina, 28211, United States

RECRUITING

Clinical Site

Cypress, Texas, 77429, United States

RECRUITING

Clinical Site

San Antonio, Texas, 78229, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Clinical Site

Blagoevgrad, 2700, Bulgaria

RECRUITING

Clinical Site

Cherven Bryag, 5980, Bulgaria

RECRUITING

Clinical Site

Sofia, 1377, Bulgaria

RECRUITING

Clinical Site

Sofia, 1408, Bulgaria

RECRUITING

Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Clinical Site

Sofia, 1680, Bulgaria

RECRUITING

Clinical Site

Stara Zagora, 6000, Bulgaria

RECRUITING

Clinical Site

Vratsa, 3000, Bulgaria

RECRUITING

Clinical Site_2

Zagreb, 10000, Croatia

RECRUITING

Clinical Site

Zagreb, 10000, Croatia

RECRUITING

Clinical Site

Zagreb, 10090, Croatia

RECRUITING

Clinical Site

Brno, 60200, Czechia

RECRUITING

Clinical Site

Brno, 62800, Czechia

RECRUITING

Clinical Site

Hradec Králové, 50002, Czechia

RECRUITING

Clinical Site

Prague, 18600, Czechia

RECRUITING

Clinical Site

Bydgoszcz, 85-080, Poland

RECRUITING

Clinical Site

Ścinawa, 59-330, Poland

RECRUITING

Clinical Site

Bucharest, 10825, Romania

RECRUITING

Clinical Site

Bucharest, 40874, Romania

RECRUITING

Clinical Site

Bucharest, 41914, Romania

RECRUITING

Clinical Site

Bucharest, 60222, Romania

RECRUITING

Clinical Site

Galati, 800179, Romania

RECRUITING

Clinical Site

Sibiu, 550281, Romania

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Kovin, 26220, Serbia

RECRUITING

Clinical Site

Kragujevac, 34000, Serbia

RECRUITING

Clinical Site

Niš, 18000, Serbia

RECRUITING

Clinical Site

Novi Kneževac, 23330, Serbia

RECRUITING

Clinical Site

Banská Bystrica, 97404, Slovakia

RECRUITING

Clinical Site

Bratislava, 81369, Slovakia

RECRUITING

Clinical Site

Košice, 4001, Slovakia

RECRUITING

Clinical Site

Košice, 4190, Slovakia

RECRUITING

Clinical Site

Krompachy, 5342, Slovakia

RECRUITING

Clinical Site

Vranov nad Topľou, 9301, Slovakia

RECRUITING

Clinical Site

Albacete, 2006, Spain

RECRUITING

Clinical Site

Madrid, 28046, Spain

NOT YET RECRUITING

Clinical Site

Zamora, 49021, Spain

NOT YET RECRUITING

Clinical Site

Zaragoza, 50012, Spain

RECRUITING

Central Study Contacts

ITI Clinical Trials

CONTACT

6464409333; 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: August 2, 2024
• First Posted: August 6, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); CZ (4); US (27); CR (3); SL (6); BU (8); PL (2); SE (5); RO (6)