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

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: Agitation Associated With Alzheimer's Dementia
• Intervention / Treatment: Drug: ITI-1284; Drug: Placebo

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

• Study Contact: Name: ITI Clinical Trials; Phone Number: 646-440-9333; Email: ITCIClinicalTrials@itci-inc.com

Study Locations

• Bulgaria
  • Lovech, Bulgaria, 5500
    • Recruiting
    • State Psychiatric Hospital - Lovech
  • Pleven, Bulgaria, 5800
    • Recruiting
    • Medical Center Medconsult-Pleven
  • 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
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University hospital centre Zagreb
  • Zagreb, Croatia, 10000
    • Completed
    • University Hospital Centre Zagreb 1
  • Zagreb, Croatia, 10090
    • Recruiting
    • Psychiatric Clinic "VRAPCE"
  • Zagreb, Croatia, 10090
    • Recruiting
    • Psychiatric Hospital Sveti Ivan
• Czechia
  • Brno, Czechia, 602 00
    • Recruiting
    • Fakultni Nemocnice u sv. Anny v Brne
  • Choceň, Czechia, 56501
    • Recruiting
    • NEUROHK s r o
  • Kutná Hora, Czechia, 284 01
    • Recruiting
    • Neuroterapie KH S R O
  • Pilsen, Czechia, 301 00
    • Recruiting
    • A Shine S R O
  • Prague, Czechia, 100 00
    • Recruiting
    • Clintrial s r o
  • Prague, Czechia, 160 00
    • Recruiting
    • NeuropsychiatrieHK, s.r.o.
• 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
    • Recruiting
    • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
  • Com Sanpetru, Romania, 507190
    • Recruiting
    • Spitalul de Psihiatrie și Neurologie Brașov
  • Sibiu, Romania, 550281
    • Recruiting
    • SC Carpe Diem SRL
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Institute of Mental Health Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Clinical Center Dr Dragisa Misovic Dedinje
  • Kovin, Serbia, 26220
    • Completed
    • Special Hospital for Psychiatric Diseases Kovin
  • 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
    • Recruiting
    • Neurologicka ambulancia MUDr.Dupejova s.r.o.
  • Bratislava, Slovakia, 81369
    • Recruiting
    • Univerzitna nemocnica Bratislava
  • Košice, Slovakia, 4001
    • Recruiting
    • Epamed sro
  • Krompachy, Slovakia, 05342
    • Recruiting
    • NEURES s r o
  • Svidník, Slovakia, 089 01
    • Recruiting
    • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
  • Vranov nad Topľou, Slovakia, 09301
    • Recruiting
    • Crystal Comfort s.r.o.
• Spain
  • Albacete, Spain, 02006
    • Recruiting
    • Hosp. Gral. de Albacete
  • Badalona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol
  • Málaga, Spain, 29004
    • Recruiting
    • Hosp. Quirónsalud Málaga
  • Zamora, Spain, 49021
    • Recruiting
    • Hosp. Prov. de Zamora
  • Zaragoza, Spain, 50012
    • Recruiting
    • Hosp. Viamed Montecanal
• United States
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Advanced Research Center, Inc
    • Costa Mesa, California, United States, 92626
      • Recruiting
      • ATP Clinical Research
    • Garden Grove, California, United States, 92844
      • Completed
      • National Institute of Clinical Research
    • Newport Beach, California, United States, 92660
      • Completed
      • Wr Pri Llc
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Recruiting
      • SFM Clinical Research
    • Bonita Springs, Florida, United States, 34134
      • Recruiting
      • Envision Trials LLC
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Clinical Research of Brandon
    • Delray Beach, Florida, United States, 33445
      • Completed
      • Brain Matters Research
    • Doral, Florida, United States, 33178
      • Recruiting
      • Science Connections LLC
    • Hialeah, Florida, United States, 33012-3618
      • Recruiting
      • Direct Helpers Medical Center, Inc.
    • Homestead, Florida, United States, 33033
      • Recruiting
      • Homestead Associates In Research Inc
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research
    • Maitland, Florida, United States, 32751
      • Recruiting
      • Neurology Associates PA
    • Miami, Florida, United States, 33155-4630
      • Recruiting
      • Allied Biomedical Research Institute (ABRI), Inc
    • Miami, Florida, United States, 33122
      • Recruiting
      • Vital Care Research
    • Miami, Florida, United States, 33135
      • Recruiting
      • Wellness Research Center
    • Miami, Florida, United States, 33135
      • Recruiting
      • Advanced Clinical Research Network
    • Miami, Florida, United States, 33166
      • Recruiting
      • South Florida Research Phase I-IV
    • Miami, Florida, United States, 33135
      • Suspended
      • Advance Medical Research Center
    • Miami, Florida, United States, 33180
      • Recruiting
      • Miami Jewish Health System
    • Miami, Florida, United States, 33186
      • Recruiting
      • Sunshine Medical Research Studies Inc
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Charter Research
    • Orlando, Florida, United States, 32807
      • Completed
      • Combined Research Orlando
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Psych Me Medical Research Inc
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Quantum Research Associates Corp
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Premiere Research Institute at Palm Beach Neurology
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Recruiting
      • Oasis Clinical Research LLC
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • Bio Behavioral Health
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Completed
      • Eximia Clinical Research NC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Suspended
      • UT Health San Antonio

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: Intra-Cellular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 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 (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: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Alzheimer Disease; Dementia; Psychomotor Agitation
• 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