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Agitation Associated With Alzheimer's DementiaPhase 2NCT06651567

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

A Phase 2 study testing ITI-1284 in people with Agitation Associated With Alzheimer's Dementia, run by Intra-Cellular Therapies, Inc. at 71 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
ITI-1284
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
71 sitesin 8 countries
Study dates
22 Oct 2024to 28 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 as detected by an appropriately validated test; 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;

Who cannot join

  • 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.

Trial locations and contacts

71 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

71 sites in 8 countries

United States32 sites, 24 recruiting

  • Advanced Research Center, Inc

    Anaheim, California, 92805

    Recruiting

  • SFM Clinical Research LLC

    Boca Raton, Florida, 33487

    Recruiting

  • Envision Trials LLC

    Bonita Springs, Florida, 34134

    Recruiting

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

    Recruiting

  • Clinical Research of Brandon

    Brandon, Florida, 33511

    Recruiting

  • ATP Clinical Research

    Costa Mesa, California, 92626

    Completed

  • Brain Matters Research

    Delray Beach, Florida, 33445

    Completed

  • Science Connections LLC

    Doral, Florida, 33178

    Recruiting

  • National Institute Of Clinical Research

    Garden Grove, California, 92844

    Completed

  • Direct Helpers Medical Center, Inc.

    Hialeah, Florida, 33012-3618

    Recruiting

  • Homestead Associates in Research Inc

    Homestead, Florida, 33033

    Recruiting

  • Oasis Clinical Research LLC

    Las Vegas, Nevada, 89121

    Recruiting

  • K2 Medical Research

    Maitland, Florida, 32751

    Recruiting

  • Neurology Associates PA

    Maitland, Florida, 32751

    Recruiting

  • Vital Care Research

    Miami, Florida, 33122

    Recruiting

  • Advance Medical Research Center

    Miami, Florida, 33135

    Suspended

  • Advanced Clinical Research Network

    Miami, Florida, 33135

    Recruiting

  • Wellness Research Center

    Miami, Florida, 33135

    Recruiting

  • Allied Biomedical Research Institute (ABRI), Inc

    Miami, Florida, 33155-4630

    Recruiting

  • South Florida Research Phase I-IV

    Miami, Florida, 33166

    Recruiting

  • Miami Jewish Health System

    Miami, Florida, 33180

    Completed

  • Sunshine Medical Research Studies Inc

    Miami, Florida, 33186

    Recruiting

  • Wr Pri Llc

    Newport Beach, California, 92660

    Completed

  • Charter Research

    Orlando, Florida, 32803

    Recruiting

  • Combined Research Orlando

    Orlando, Florida, 32807

    Completed

  • Eximia Clinical Research NC

    Raleigh, North Carolina, 27607

    Completed

  • UT Health San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Psych Me Medical Research Inc

    Tampa, Florida, 33614

    Recruiting

  • Quantum Research Associates Corp

    Tampa, Florida, 33614

    Recruiting

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

    Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    Recruiting

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

Bulgaria7 sites, 7 recruiting

  • State Psychiatric Hospital - Lovech

    Lovech, 5500

    Recruiting

  • Medical Center Medconsult-Pleven

    Pleven, 5800

    Recruiting

  • Mental Health Centre Prof. N Shipkovenski EOOD

    Sofia, 1377

    Recruiting

  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

    Sofia, 1408

    Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510

    Recruiting

  • Medical Center Intermedica, OOD

    Sofia, 1680

    Recruiting

  • UMHAT Prof. Dr. St. Kirkovich AD

    Stara Zagora, 6003

    Recruiting

Other trials in Bulgaria

Czechia6 sites, 6 recruiting

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 602 00

    Recruiting

  • NEUROHK s r o

    Choceň, 56501

    Recruiting

  • Neuroterapie KH S R O

    Kutná Hora, 284 01

    Recruiting

  • A Shine S R O

    Pilsen, 301 00

    Recruiting

  • Clintrial s r o

    Prague, 100 00

    Recruiting

  • NeuropsychiatrieHK, s.r.o.

    Prague, 160 00

    Recruiting

Other trials in Czechia

Romania6 sites, 6 recruiting

  • Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

    Bucharest, 010825

    Recruiting

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1

    Bucharest, 040874

    Recruiting

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

    Bucharest, 041914

    Recruiting

  • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian

    Bucharest, 60222

    Recruiting

  • Spitalul de Psihiatrie si Neurologie Brasov

    Com Sanpetru, 507190

    Recruiting

  • SC Carpe Diem SRL

    Sibiu, 550281

    Recruiting

Other trials in Romania

Slovakia6 sites, 6 recruiting

  • Neurologicka ambulancia MUDr.Dupejova s.r.o.

    Banská Bystrica, 97404

    Recruiting

  • Univerzitna nemocnica Bratislava

    Bratislava, 81369

    Recruiting

  • Epamed sro

    Košice, 4001

    Recruiting

  • NEURES s r o

    Krompachy, 05342

    Recruiting

  • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.

    Svidník, 089 01

    Recruiting

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 09301

    Recruiting

Other trials in Slovakia

Serbia5 sites, 3 recruiting

  • Clinical Center Dr Dragisa Misovic Dedinje

    Belgrade, 11000

    Recruiting

  • Institute of Mental Health Serbia

    Belgrade, 11000

    Recruiting

  • Special Hospital for Psychiatric Diseases Kovin

    Kovin, 26220

    Completed

  • University Clinical Center NIS

    Niš, 18000

    Recruiting

  • Special Hospital for Psychiatric Diseases Sveti Vracevi

    Novi Kneževac, 23330

    Suspended

Other trials in Serbia

Spain5 sites, 4 recruiting

  • Hosp. Gral. de Albacete

    Albacete, 02006

    Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

    Recruiting

  • Hosp. Quirónsalud Málaga

    Málaga, 29004

    Recruiting

  • Hosp. Prov. de Zamora

    Zamora, 49021

    Recruiting

  • Hosp. Viamed Montecanal

    Zaragoza, 50012

    Suspended

Other trials in Spain

Croatia4 sites, 3 recruiting

  • University Hospital Centre Zagreb 1

    Zagreb, 10000

    Completed

  • University Hospital Centre Zagreb

    Zagreb, 10000

    Recruiting

  • Psychiatric Clinic "VRAPCE"

    Zagreb, 10090

    Recruiting

  • Psychiatric Hospital Sveti Ivan

    Zagreb, 10090

    Recruiting

Other trials in Croatia

About this study

Official title: 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.

Being tested
ITI-1284, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITI-1284Drug

    ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

  • PlaceboDrug

    Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Study groups in NCT06651567
Study groupRoleWhat they receive
ITI-1284ExperimentalITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Receives: Drug: ITI-1284
PlaceboPlacebo comparatorPlacebo rapidly disintegrating tablet, taken once daily, sublingual administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

Secondary outcomes (1)

  1. 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)

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completion28 Dec 2027 (estimated)
  4. Study completion28 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651567
Sponsor's protocol ID
ITI-1284-101
Status last verified
Nov 2026
First submitted
18 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ITI-1284 in people with Agitation Associated With Alzheimer's Dementia, run by Intra-Cellular Therapies, Inc. at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Bulgaria, Czechia, Romania, Slovakia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohen-Mansfield Agitation Inventory (CMAI) total score (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06651567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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