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

January 12, 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
        • Clinical Site
      • Cherven Bryag, Bulgaria, 5980
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1408
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1377
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Clinical Site
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Clinical Site
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Clinical Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Site
      • Zagreb, Croatia, 10090
        • Recruiting
        • Clinical Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Site_2
  • Czechia
      • Brno, Czechia, 60200
        • Recruiting
        • Clinical Site
      • Brno, Czechia, 62800
        • Recruiting
        • Clinical Site
      • Hradec Králové, Czechia, 50002
        • Recruiting
        • Clinical Site
      • Prague, Czechia, 18600
        • Recruiting
        • Clinical Site
  • Poland
      • Bydgoszcz, Poland, 85-080
        • Recruiting
        • Clinical Site
      • Ścinawa, Poland, 59-330
        • Recruiting
        • Clinical Site
  • Romania
      • Bucharest, Romania, 10825
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 40874
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 41914
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 60222
        • Recruiting
        • Clinical Site
      • Galati, Romania, 800179
        • Recruiting
        • Clinical Site
      • Sibiu, Romania, 550281
        • Recruiting
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Kovin, Serbia, 26220
        • Recruiting
        • Clinical Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Clinical Site
      • Niš, Serbia, 18000
        • Recruiting
        • Clinical Site
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Clinical Site
  • Slovakia
      • Banská Bystrica, Slovakia, 97404
        • Recruiting
        • Clinical Site
      • Bratislava, Slovakia, 81369
        • Recruiting
        • Clinical Site
      • Košice, Slovakia, 4001
        • Recruiting
        • Clinical Site
      • Košice, Slovakia, 4190
        • Recruiting
        • Clinical Site
      • Krompachy, Slovakia, 5342
        • Recruiting
        • Clinical Site
      • Vranov nad Topľou, Slovakia, 9301
        • Recruiting
        • Clinical Site
  • Spain
      • Albacete, Spain, 2006
        • Recruiting
        • Clinical Site
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Clinical Site
      • Zamora, Spain, 49021
        • Not yet recruiting
        • Clinical Site
      • Zaragoza, Spain, 50012
        • Recruiting
        • Clinical Site
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinical Site
      • Costa Mesa, California, United States, 92626
        • Active, not recruiting
        • Clinical Site
      • Lafayette, California, United States, 94549
        • Not yet recruiting
        • Clinical Site
      • Los Alamitos, California, United States, 90720
        • Withdrawn
        • Clinical Site
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Clinical Site
      • Orange, California, United States, 92866
        • Recruiting
        • Clinical Site
    • Florida
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Clinical Site
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Site
      • Coral Springs, Florida, United States, 33067
        • Recruiting
        • Clinical Site
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Clinical Site
      • Doral, Florida, United States, 33178
        • Recruiting
        • Clinical Site
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33155
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33186
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33166
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Clinical Site
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Clinical Site
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Clinical Site
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Clinical Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Clinical Site
    • Texas
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Clinical Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Clinical Site

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 1, 2027

Study Completion (Estimated)

October 1, 2027

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)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 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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