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New pill aims to soothe Alzheimer's agitation in major trial

NCT ID NCT06651567

Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 7 times

Summary

This study tests an experimental drug called ITI-1284 to see if it can safely reduce agitation in people with Alzheimer's dementia. About 320 participants will receive either the drug or a placebo, and researchers will measure changes in agitated behaviors using a caregiver questionnaire. The goal is to improve quality of life for patients and their families.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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; 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation associated with Alzheimer's dementia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A Shine S R O

    RECRUITING

    Pilsen, 301 00, Czechia

  • ATP Clinical Research

    COMPLETED

    Costa Mesa, California, 92626, United States

  • Advance Medical Research Center

    SUSPENDED

    Miami, Florida, 33135, United States

  • Advanced Clinical Research Network

    RECRUITING

    Miami, Florida, 33135, United States

  • Advanced Research Center, Inc

    RECRUITING

    Anaheim, California, 92805, United States

  • Allied Biomedical Research Institute (ABRI), Inc

    RECRUITING

    Miami, Florida, 33155-4630, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Brain Matters Research

    COMPLETED

    Delray Beach, Florida, 33445, United States

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

    RECRUITING

    Bucharest, 60222, Romania

  • Charter Research

    RECRUITING

    Orlando, Florida, 32803, United States

  • Clinical Center Dr Dragisa Misovic Dedinje

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Research of Brandon

    RECRUITING

    Brandon, Florida, 33511, United States

  • Clintrial s r o

    RECRUITING

    Prague, 100 00, Czechia

  • Combined Research Orlando

    COMPLETED

    Orlando, Florida, 32807, United States

  • Crystal Comfort s.r.o.

    RECRUITING

    Vranov nad Topľou, 09301, Slovakia

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

    RECRUITING

    Sofia, 1408, Bulgaria

  • Direct Helpers Medical Center, Inc.

    RECRUITING

    Hialeah, Florida, 33012-3618, United States

  • Envision Trials LLC

    RECRUITING

    Bonita Springs, Florida, 34134, United States

  • Epamed sro

    RECRUITING

    Košice, 4001, Slovakia

  • Eximia Clinical Research NC

    COMPLETED

    Raleigh, North Carolina, 27607, United States

  • Fakultni nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, 602 00, Czechia

  • Homestead Associates in Research Inc

    RECRUITING

    Homestead, Florida, 33033, United States

  • Hosp. Gral. de Albacete

    RECRUITING

    Albacete, 02006, Spain

  • Hosp. Prov. de Zamora

    RECRUITING

    Zamora, 49021, Spain

  • Hosp. Quirónsalud Málaga

    RECRUITING

    Málaga, 29004, Spain

  • Hosp. Viamed Montecanal

    SUSPENDED

    Zaragoza, 50012, Spain

  • Hospital Universitari Germans Trias i Pujol

    SUSPENDED

    Badalona, 08916, Spain

  • Institute of Mental Health Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • K2 Medical Research

    RECRUITING

    Maitland, Florida, 32751, United States

  • Medical Center Hera EOOD

    RECRUITING

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica, OOD

    RECRUITING

    Sofia, 1680, Bulgaria

  • Medical Center Medconsult-Pleven

    RECRUITING

    Pleven, 5800, Bulgaria

  • Mental Health Centre Prof. N Shipkovenski EOOD

    RECRUITING

    Sofia, 1377, Bulgaria

  • Miami Jewish Health System

    COMPLETED

    Miami, Florida, 33180, United States

  • NEURES s r o

    RECRUITING

    Krompachy, 05342, Slovakia

  • NEUROHK s r o

    RECRUITING

    Choceň, 56501, Czechia

  • National Institute Of Clinical Research

    COMPLETED

    Garden Grove, California, 92844, United States

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

    RECRUITING

    Banská Bystrica, 97404, Slovakia

  • Neurology Associates PA

    RECRUITING

    Maitland, Florida, 32751, United States

  • NeuropsychiatrieHK, s.r.o.

    RECRUITING

    Prague, 160 00, Czechia

  • Neuroterapie KH S R O

    RECRUITING

    Kutná Hora, 284 01, Czechia

  • Oasis Clinical Research LLC

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Premiere Research Institute at Palm Beach Neurology

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Psych Me Medical Research Inc

    RECRUITING

    Tampa, Florida, 33614, United States

  • Psychiatric Clinic "VRAPCE"

    RECRUITING

    Zagreb, 10090, Croatia

  • Psychiatric Hospital Sveti Ivan

    RECRUITING

    Zagreb, 10090, Croatia

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

    RECRUITING

    Svidník, 089 01, Slovakia

  • Quantum Research Associates Corp

    RECRUITING

    Tampa, Florida, 33614, United States

  • SC Carpe Diem SRL

    RECRUITING

    Sibiu, 550281, Romania

  • SFM Clinical Research LLC

    RECRUITING

    Boca Raton, Florida, 33487, United States

  • Science Connections LLC

    RECRUITING

    Doral, Florida, 33178, United States

  • South Florida Research Phase I-IV

    RECRUITING

    Miami, Florida, 33166, United States

  • Special Hospital for Psychiatric Diseases Kovin

    COMPLETED

    Kovin, 26220, Serbia

  • Special Hospital for Psychiatric Diseases Sveti Vracevi

    RECRUITING

    Novi Kneževac, 23330, Serbia

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

    RECRUITING

    Bucharest, 041914, Romania

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1

    RECRUITING

    Bucharest, 040874, Romania

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

    RECRUITING

    Bucharest, 010825, Romania

  • Spitalul de Psihiatrie si Neurologie Brasov

    RECRUITING

    Com Sanpetru, 507190, Romania

  • State Psychiatric Hospital - Lovech

    RECRUITING

    Lovech, 5500, Bulgaria

  • Sunshine Medical Research Studies Inc

    RECRUITING

    Miami, Florida, 33186, United States

  • Tufts University School of Medicine

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UMHAT Prof. Dr. St. Kirkovich AD

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • UT Health San Antonio

    SUSPENDED

    San Antonio, Texas, 78229, United States

  • University Clinical Center NIS

    RECRUITING

    Niš, 18000, Serbia

  • University Hospital Centre Zagreb

    RECRUITING

    Zagreb, 10000, Croatia

  • University Hospital Centre Zagreb 1

    COMPLETED

    Zagreb, 10000, Croatia

  • Univerzitna nemocnica Bratislava

    SUSPENDED

    Bratislava, 81369, Slovakia

  • Vital Care Research

    RECRUITING

    Miami, Florida, 33122, United States

  • Wellness Research Center

    RECRUITING

    Miami, Florida, 33135, United States

  • Wr Pri Llc

    COMPLETED

    Newport Beach, California, 92660, United States