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New pill aims to calm Alzheimer's psychosis in landmark trial

NCT ID NCT06540833

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 6 times

Summary

This study tests an experimental drug, ITI-1284, to see if it can safely reduce psychosis symptoms like hallucinations and delusions in people with Alzheimer's disease. About 370 participants will receive either the drug or a placebo, and doctors will track changes in symptom severity over time. The goal is to improve quality of life for patients and their caregivers.

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 370 people

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

Started

Aug 2024

Expected to finish

Dec 2028

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: 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 as detected by an appropriately validated test; 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 (for example, 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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease psychotic disorder Psychotic Disorders

As listed by the trial registrant

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

Alzheimer disease Psychosis associated with Alzheimer's disease Psychotic disorders

How to take part

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

  1. The places running it

    52 sites in 9 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

  • ATP Clinical Research

    COMPLETED

    Orange, California, 92866, 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

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

    SUSPENDED

    Cherven Bryag, 5980, Bulgaria

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

    RECRUITING

    Brescia, 25123, Italy

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Brain Matters Research

    COMPLETED

    Delray Beach, Florida, 33445, United States

  • CenExeli Research LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

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

    SUSPENDED

    Bucharest, 60222, Romania

  • Clinical Center Dr Dragisa Misovic Dedinje

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Research of Brandon

    RECRUITING

    Brandon, Florida, 33511, United States

  • Combined Research Orlando

    COMPLETED

    Orlando, Florida, 32803, 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

  • Envision Trials LLC

    RECRUITING

    Bonita Springs, Florida, 34134, United States

  • Epamed sro

    RECRUITING

    Košice, 4001, Slovakia

  • Fakultni nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, 60200, Czechia

  • Healthcare Innovations Institute Inc

    COMPLETED

    Coral Springs, Florida, 33067, United States

  • Homestead Associates in Research Inc

    RECRUITING

    Homestead, Florida, 33033, United States

  • Horizon Clinical Research Group

    RECRUITING

    Cypress, Texas, 77065, United States

  • Hosp. Gral. de Albacete

    SUSPENDED

    Albacete, 02006, Spain

  • Hosp. Prov. de Zamora

    RECRUITING

    Zamora, 49021, Spain

  • Hosp. Viamed Montecanal

    SUSPENDED

    Zaragoza, 50012, Spain

  • INEP medical s.r.o.

    COMPLETED

    Prague, 18600, Czechia

  • Intercoastal Medical Group

    RECRUITING

    Sarasota, Florida, 34239, United States

  • 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 Sv Dimitar Blagoevgrad

    RECRUITING

    Blagoevgrad, 2700, Bulgaria

  • Mental Health Center - Vratsa EOOD

    COMPLETED

    Vratsa, 3000, Bulgaria

  • Mental Health Centre Prof. N Shipkovenski EOOD

    RECRUITING

    Sofia, 1377, Bulgaria

  • NEURES s r o

    RECRUITING

    Krompachy, 05342, Slovakia

  • NEUROHK s r o

    RECRUITING

    Hradec Králové, 50002, Czechia

  • Neuro Care

    COMPLETED

    Katowice, 40-749, Poland

  • Neuro Health Centrum s r o

    RECRUITING

    Brno, 62800, Czechia

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

    COMPLETED

    Banská Bystrica, 97404, Slovakia

  • New Hope Clinical Research

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Ocean Blue Medical Research Center Inc.

    SUSPENDED

    Miami, Florida, 33144, United States

  • Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu

    COMPLETED

    Ścinawa, 59-330, Poland

  • Pharmacology Research Institute

    COMPLETED

    Los Alamitos, California, 90720, United States

  • Polyclinic Neuron

    RECRUITING

    Zagreb, 10000, Croatia

  • Przychodnia Srodmiescie SP. z o.o.

    COMPLETED

    Bydgoszcz, 85 080, Poland

  • Psych Me Medical Research Inc

    COMPLETED

    Tampa, Florida, 33614, United States

  • Psychiatric Clinic "VRAPCE"

    RECRUITING

    Zagreb, 10090, Croatia

  • SC Carpe Diem SRL

    RECRUITING

    Sibiu, 550281, Romania

  • 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 De Psihiatrie Elisabeta Doamna Galaţi

    RECRUITING

    Galati, 800179, Romania

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

    RECRUITING

    Bucharest, 010825, Romania

  • Sunshine Medical Solution

    SUSPENDED

    Miami, Florida, 33186, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • UMHAT Prof. Dr. St. Kirkovich AD

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • 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

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229-3900, United States

  • Univerzitna nemocnica Bratislava

    SUSPENDED

    Bratislava, 81369, Slovakia

  • Univerzitna nemocnica L. Pasteura Kosice

    RECRUITING

    Košice, 04190, Slovakia

  • Wellness Research Center

    SUSPENDED

    Miami, Florida, 33135, United States

  • Wr Pri Llc

    COMPLETED

    Newport Beach, California, 92660, United States

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