NCT06540833From ClinicalTrials.govRecruiting

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease

Psychotic Disorders
Alzheimer Disease

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 370
Started: 15 August 2024
Main results due: 30 September 2028
Study sites: 69
Registry updated: 29 September 2026

Can you take part?

Aged 55 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Study sites(69)

Advanced Research Center, Inc
Anaheim, California, United States
Recruiting
Pharmacology Research Institute
Los Alamitos, California, United States
Completed
Wr Pri Llc
Newport Beach, California, United States
Completed
ATP Clinical Research
Orange, California, United States
Completed
Sunwise Clinical Research
Walnut Creek, California, United States
Recruiting
Envision Trials LLC
Bonita Springs, Florida, United States
Recruiting
Clinical Research of Brandon
Brandon, Florida, United States
Recruiting
Healthcare Innovations Institute Inc
Coral Springs, Florida, United States
Completed
Brain Matters Research
Delray Beach, Florida, United States
Completed
Science Connections LLC
Doral, Florida, United States
Recruiting
Homestead Associates in Research Inc
Homestead, Florida, United States
Recruiting
K2 Medical Research
Maitland, Florida, United States
Recruiting
Wellness Research Center
Miami, Florida, United States
Suspended
Ocean Blue Medical Research Center Inc.
Miami, Florida, United States
Suspended
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida, United States
Recruiting
South Florida Research Phase I-IV
Miami, Florida, United States
Recruiting
Sunshine Medical Solution
Miami, Florida, United States
Suspended
Combined Research Orlando
Orlando, Florida, United States
Completed
Intercoastal Medical Group
Sarasota, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
Psych Me Medical Research Inc
Tampa, Florida, United States
Completed
CenExeli Research LLC
Savannah, Georgia, United States
Recruiting
Bio Behavioral Health
Toms River, New Jersey, United States
Recruiting
New Hope Clinical Research
Charlotte, North Carolina, United States
Recruiting
AMC Research, LLC
Matthews, North Carolina, United States
Recruiting
Horizon Clinical Research Group
Cypress, Texas, United States
Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Medical Center Sv Dimitar Blagoevgrad
Blagoevgrad, Bulgaria
Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
Cherven Bryag, Bulgaria
Suspended
Mental Health Centre Prof. N Shipkovenski EOOD
Sofia, Bulgaria
Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, Bulgaria
Recruiting
Medical Center Hera EOOD
Sofia, Bulgaria
Suspended
Medical Center Intermedica, OOD
Sofia, Bulgaria
Recruiting
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, Bulgaria
Recruiting
Mental Health Center - Vratsa EOOD
Vratsa, Bulgaria
Completed
Polyclinic Neuron
Zagreb, Croatia
Recruiting
University Hospital Centre Zagreb 1
Zagreb, Croatia
Completed
University Hospital Centre Zagreb
Zagreb, Croatia
Recruiting
Psychiatric Clinic "VRAPCE"
Zagreb, Croatia
Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Recruiting
Neuro Health Centrum s r o
Brno, Czechia
Recruiting
NEUROHK s r o
Hradec Králové, Czechia
Recruiting
INEP medical s.r.o.
Prague, Czechia
Completed
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, Italy
Recruiting
Fondazione Istituto G. Giglio
Cefalù, Italy
Recruiting
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, Poland
Completed
Neuro Care
Katowice, Poland
Completed
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu
Ścinawa, Poland
Completed
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
Bucharest, Romania
Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1
Bucharest, Romania
Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, Romania
Recruiting
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
Bucharest, Romania
Suspended
Spitalul De Psihiatrie Elisabeta Doamna Galaţi
Galati, Romania
Recruiting
SC Carpe Diem SRL
Sibiu, Romania
Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia
Recruiting
Special Hospital for Psychiatric Diseases Kovin
Kovin, Serbia
Completed
University Clinical Center Kragujevac
Kragujevac, Serbia
Recruiting
University Clinical Center NIS
Niš, Serbia
Recruiting
Special Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, Serbia
Recruiting

Showing 60 of 69 sites — filter to narrow it down. 45 of the 69 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06540833. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me