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
- Agitation Associated With Alzheimer's Dementia
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Intra-Cellular Therapies, Inc.
- Enrolment target
- 320
- Started
- 22 October 2024
- Main results due
- 28 December 2027
- Study sites
- 70
- 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: * 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(70)
Advanced Research Center, Inc
Anaheim, California, United States
Recruiting
ATP Clinical Research
Costa Mesa, California, United States
Completed
National Institute Of Clinical Research
Garden Grove, California, United States
Completed
Wr Pri Llc
Newport Beach, California, United States
Completed
SFM Clinical Research LLC
Boca Raton, Florida, United States
Recruiting
Envision Trials LLC
Bonita Springs, Florida, United States
Recruiting
Clinical Research of Brandon
Brandon, Florida, United States
Recruiting
Brain Matters Research
Delray Beach, Florida, United States
Completed
Science Connections LLC
Doral, Florida, United States
Recruiting
Direct Helpers Medical Center, Inc.
Hialeah, Florida, United States
Recruiting
Homestead Associates in Research Inc
Homestead, Florida, United States
Recruiting
K2 Medical Research
Maitland, Florida, United States
Recruiting
Neurology Associates PA
Maitland, Florida, United States
Recruiting
Vital Care Research
Miami, Florida, United States
Recruiting
Advance Medical Research Center
Miami, Florida, United States
Suspended
Advanced Clinical Research Network
Miami, Florida, United States
Recruiting
Wellness Research Center
Miami, Florida, United States
Recruiting
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida, United States
Recruiting
South Florida Research Phase I-IV
Miami, Florida, United States
Recruiting
Miami Jewish Health System
Miami, Florida, United States
Completed
Sunshine Medical Research Studies Inc
Miami, Florida, United States
Recruiting
Charter Research
Orlando, Florida, United States
Recruiting
Combined Research Orlando
Orlando, Florida, United States
Completed
Psych Me Medical Research Inc
Tampa, Florida, United States
Recruiting
Quantum Research Associates Corp
Tampa, Florida, United States
Recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Recruiting
Tufts University School of Medicine
Boston, Massachusetts, United States
Recruiting
Oasis Clinical Research LLC
Las Vegas, Nevada, United States
Recruiting
Bio Behavioral Health
Toms River, New Jersey, United States
Recruiting
Eximia Clinical Research NC
Raleigh, North Carolina, United States
Completed
UT Health San Antonio
San Antonio, Texas, United States
Recruiting
State Psychiatric Hospital - Lovech
Lovech, Bulgaria
Recruiting
Medical Center Medconsult-Pleven
Pleven, Bulgaria
Recruiting
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
Recruiting
Medical Center Intermedica, OOD
Sofia, Bulgaria
Recruiting
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, Bulgaria
Recruiting
University Hospital Centre Zagreb 1
Zagreb, Croatia
Completed
University Hospital Centre Zagreb
Zagreb, Croatia
Recruiting
Psychiatric Clinic "VRAPCE"
Zagreb, Croatia
Recruiting
Psychiatric Hospital Sveti Ivan
Zagreb, Croatia
Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Recruiting
NEUROHK s r o
Choceň, Czechia
Recruiting
Neuroterapie KH S R O
Kutná Hora, Czechia
Recruiting
A Shine S R O
Pilsen, Czechia
Recruiting
Clintrial s r o
Prague, Czechia
Recruiting
NeuropsychiatrieHK, s.r.o.
Prague, Czechia
Recruiting
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
Recruiting
Spitalul de Psihiatrie si Neurologie Brasov
Com Sanpetru, Romania
Recruiting
SC Carpe Diem SRL
Sibiu, Romania
Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia
Recruiting
Institute of Mental Health Serbia
Belgrade, Serbia
Recruiting
Special Hospital for Psychiatric Diseases Kovin
Kovin, Serbia
Completed
University Clinical Center NIS
Niš, Serbia
Recruiting
Special Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, Serbia
Recruiting
Neurologicka ambulancia MUDr.Dupejova s.r.o.
Banská Bystrica, Slovakia
Recruiting
Showing 60 of 70 sites — filter to narrow it down. 57 of the 70 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 NCT06651567. 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.
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