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

January 9, 2026 updated by: Intra-Cellular Therapies, Inc.

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

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

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 (12 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)

320

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
      • Lovech, Bulgaria, 5500
        • Recruiting
        • Clinical Site
      • Pleven, Bulgaria, 5800
        • 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
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Site
      • Zagreb, Croatia, 10090
        • Recruiting
        • Clinical Site
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Site_2
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Site_3
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • Clinical Site
      • Choceň, Czechia, 56501
        • Recruiting
        • Clinical Site
      • Kutná Hora, Czechia, 284 01
        • Recruiting
        • Clinical Site
      • Pilsen, Czechia, 30100
        • Recruiting
        • Clinical Site
      • Prague, Czechia, 100 00
        • Recruiting
        • Clinical Site
      • Prague, Czechia, 160 00
        • Recruiting
        • Clinical Site
  • Romania
      • Bucharest, Romania, 010825
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 040874
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 041914
        • Recruiting
        • Clinical Site
      • Bucharest, Romania, 060222
        • Recruiting
        • Clinical Site
      • Sibiu, Romania, 550281
        • Recruiting
        • Clinical Site
      • Sânpetru, Romania, 507190
        • Recruiting
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site_2
      • Kovin, Serbia, 26220
        • 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
      • Krompachy, Slovakia, 05342
        • Recruiting
        • Clinical Site
      • Svidník, Slovakia, 08901
        • Recruiting
        • Clinical Site
      • Vranov nad Topľou, Slovakia, 09301
        • Recruiting
        • Clinical Site
  • Spain
      • Albacete, Spain, 02006
        • Recruiting
        • Clinical Site
      • Barcelona, Spain, 08916
        • Recruiting
        • Clinical Site
      • Málaga, Spain, 29004
        • Recruiting
        • Clinical Site
      • Zamora, Spain, 49021
        • 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
        • Recruiting
        • Clinical Site
      • Garden Grove, California, United States, 92844
        • Recruiting
        • Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • Clinical Site
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Clinical Site
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Site
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Clinical Site
      • Doral, Florida, United States, 33178
        • Recruiting
        • Clinical Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Site
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Clinical Site_2
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33155
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33186
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33137
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Site_2
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Site_3
      • Miami, Florida, United States, 33166
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32807
        • Recruiting
        • Clinical Site
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Clinical Site_2
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Recruiting
        • Clinical Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Clinical Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Clinical Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • 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:

  • 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.

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
Experimental: ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Drug: ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo Comparator: Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Drug: Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen-Mansfield Agitation Inventory (CMAI) total score
Time Frame: Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Week 12
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 12

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)

October 22, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-1284-101

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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