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

July 2, 2026 updated by: Intra-Cellular Therapies, Inc.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 periods:

  • Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
  • Double-blind Treatment Period (6 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.

Study Type

Interventional

Enrollment (Estimated)

370

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Recruiting
        • Medical Center Sv Dimitar Blagoevgrad
      • Cherven Bryag, Bulgaria, 5980
        • Recruiting
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1408
        • Recruiting
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1377
        • Recruiting
        • Mental Health Centre Prof. N Shipkovenski EOOD
      • Stara Zagora, Bulgaria, 6003
        • Recruiting
        • UMHAT Prof. Dr. St. Kirkovich AD
      • Vratsa, Bulgaria, 3000
        • Completed
        • Mental Health Center - Vratsa EOOD
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Polyclinic Neuron
      • Zagreb, Croatia, 10000
        • Completed
        • University Hospital Centre Zagreb 1
      • Zagreb, Croatia, 10090
        • Recruiting
        • Psychiatric Clinic "VRAPCE"
      • Zagreb, Croatia, 10000
        • Suspended
        • University Hospital Centre Zagreb
  • Czechia
      • Brno, Czechia, 60200
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
      • Brno, Czechia, 62800
        • Recruiting
        • Neuro Health Centrum s r o
      • Hradec Králové, Czechia, 50002
        • Recruiting
        • NEUROHK s r o
      • Prague, Czechia, 18600
        • Completed
        • INEP medical s.r.o.
  • Poland
      • Bydgoszcz, Poland, 85 080
        • Completed
        • Przychodnia Srodmiescie SP. z o.o.
      • Katowice, Poland, 40-749
        • Completed
        • Neuro Care
      • Ścinawa, Poland, 59-330
        • Recruiting
        • Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu
  • Romania
      • Bucharest, Romania, 041914
        • Recruiting
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
      • Bucharest, Romania, 010825
        • Recruiting
        • Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
      • Bucharest, Romania, 040874
        • Recruiting
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
      • Bucharest, Romania, 60222
        • Suspended
        • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
      • Galati, Romania, 800179
        • Recruiting
        • Spitalul De Psihiatrie Elisabeta Doamna Galaţi
      • Sibiu, Romania, 550281
        • Recruiting
        • SC Carpe Diem SRL
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center Dr Dragisa Misovic Dedinje
      • Kovin, Serbia, 26220
        • Recruiting
        • Special Hospital for Psychiatric Diseases Kovin
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center NIS
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Special Hospital for Psychiatric Diseases Sveti Vracevi
  • Slovakia
      • Banská Bystrica, Slovakia, 97404
        • Completed
        • Neurologicka ambulancia MUDr.Dupejova s.r.o.
      • Bratislava, Slovakia, 81369
        • Suspended
        • Univerzitna nemocnica Bratislava
      • Košice, Slovakia, 04190
        • Recruiting
        • Univerzitna nemocnica L. Pasteura Kosice
      • Košice, Slovakia, 4001
        • Recruiting
        • Epamed sro
      • Krompachy, Slovakia, 05342
        • Recruiting
        • NEURES s r o
      • Vranov nad Topľou, Slovakia, 09301
        • Recruiting
        • Crystal Comfort s.r.o.
  • Spain
      • Albacete, Spain, 02006
        • Recruiting
        • Hosp. Gral. de Albacete
      • Zamora, Spain, 49021
        • Recruiting
        • Hosp. Prov. de Zamora
      • Zaragoza, Spain, 50012
        • Suspended
        • Hosp. Viamed Montecanal
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc
      • Los Alamitos, California, United States, 90720
        • Terminated
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Completed
        • Wr Pri Llc
      • Orange, California, United States, 92866
        • Suspended
        • ATP Clinical Research
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research
    • Florida
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Envision Trials LLC
      • Brandon, Florida, United States, 33511
        • Suspended
        • Clinical Research of Brandon
      • Coral Springs, Florida, United States, 33067
        • Completed
        • Healthcare Innovations Institute Inc
      • Delray Beach, Florida, United States, 33445
        • Completed
        • Brain Matters Research
      • Doral, Florida, United States, 33178
        • Recruiting
        • Science Connections LLC
      • Homestead, Florida, United States, 33033
        • Suspended
        • Homestead Associates in Research Inc
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research
      • Miami, Florida, United States, 33155-4630
        • Recruiting
        • Allied Biomedical Research Institute (ABRI), Inc
      • Miami, Florida, United States, 33135
        • Recruiting
        • Wellness Research Center
      • Miami, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV
      • Miami, Florida, United States, 33144
        • Suspended
        • Ocean Blue Medical Research Center Inc.
      • Miami, Florida, United States, 33186
        • Recruiting
        • Sunshine Medical Solution
      • Orlando, Florida, United States, 32803
        • Completed
        • Combined Research Orlando
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Intercoastal Medical Group
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
      • Tampa, Florida, United States, 33614
        • Suspended
        • Psych Me Medical Research Inc
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research
    • Texas
      • Cypress, Texas, United States, 77065
        • Recruiting
        • Horizon Clinical Research Group
      • San Antonio, Texas, United States, 78229-3900
        • Recruiting
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Bellevue, Washington, United States, 98007
        • Suspended
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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;

  2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

    1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
    2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
  3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
  4. 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;
  5. CGI-S score ≥ 4 at Screening and Baseline;
  6. 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;
  7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

Exclusion Criteria:

  1. 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:

    1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
    2. Bipolar disorder;
  2. 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;
  3. 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,
  4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia

  5. The patient is bedridden or has any significant medical condition that is unstable and would either:

    1. Place the patient at undue risk from study drug or undergoing study procedures; or
    2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
  6. The patient is in hospice or end-of-life care;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Experimental: ITI-1284
Drug: ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BEHAVE-AD psychosis subscale score
Time Frame: Week 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI-S score
Time Frame: Week 6
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)
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-1284-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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