A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Recruiting · NCT06651567 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ITI-1284Placebo
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 7 US states.
- Advanced Research Center, Inc - Anaheim, California, United States
- ATP Clinical Research - Costa Mesa, California, United States
- National Institute Of Clinical Research - Garden Grove, California, United States
- Wr Pri Llc - Newport Beach, California, United States
- SFM Clinical Research LLC - Boca Raton, Florida, United States
- Envision Trials LLC - Bonita Springs, Florida, United States
- Clinical Research of Brandon - Brandon, Florida, United States
- Brain Matters Research - Delray Beach, Florida, United States
- Science Connections LLC - Doral, Florida, United States
- Direct Helpers Medical Center, Inc. - Hialeah, Florida, United States
- Homestead Associates in Research Inc - Homestead, Florida, United States
- K2 Medical Research - Maitland, Florida, United States
- Neurology Associates PA - Maitland, Florida, United States
- Vital Care Research - Miami, Florida, United States
- Advance Medical Research Center - Miami, Florida, United States
- Advanced Clinical Research Network - Miami, Florida, United States
- Wellness Research Center - Miami, Florida, United States
- Allied Biomedical Research Institute (ABRI), Inc - Miami, Florida, United States
- South Florida Research Phase I-IV - Miami, Florida, United States
- Miami Jewish Health System - Miami, Florida, United States
- Sunshine Medical Research Studies Inc - Miami, Florida, United States
- Charter Research - Orlando, Florida, United States
- Combined Research Orlando - Orlando, Florida, United States
- Psych Me Medical Research Inc - Tampa, Florida, United States
- Quantum Research Associates Corp - Tampa, Florida, United States
- Premiere Research Institute at Palm Beach Neurology - West Palm Beach, Florida, United States
- Tufts University School of Medicine - Boston, Massachusetts, United States
- Oasis Clinical Research LLC - Las Vegas, Nevada, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- Eximia Clinical Research NC - Raleigh, North Carolina, United States
- UT Health San Antonio - San Antonio, Texas, United States
- Hosp. Gral. de Albacete - Albacete, Spain
- Hospital Universitari Germans Trias i Pujol - Badalona, Spain
- Neurologicka ambulancia MUDr.Dupejova s.r.o. - Banská Bystrica, Slovakia
- Clinical Center Dr Dragisa Misovic Dedinje - Belgrade, Serbia
- Institute of Mental Health Serbia - Belgrade, Serbia
- Univerzitna nemocnica Bratislava - Bratislava, Slovakia
- Fakultni nemocnice u sv. Anny v Brne - Brno, Czechia
- Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' - Bucharest, Romania
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1 - Bucharest, Romania
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia - Bucharest, Romania
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian - Bucharest, Romania
- NEUROHK s r o - Choceň, Czechia
- Spitalul de Psihiatrie si Neurologie Brasov - Com Sanpetru, Romania
- Special Hospital for Psychiatric Diseases Kovin - Kovin, Serbia
- Epamed sro - Košice, Slovakia
- NEURES s r o - Krompachy, Slovakia
- Neuroterapie KH S R O - Kutná Hora, Czechia
- State Psychiatric Hospital - Lovech - Lovech, Bulgaria
- Hosp. Quirónsalud Málaga - Málaga, Spain
- University Clinical Center NIS - Niš, Serbia
- Special Hospital for Psychiatric Diseases Sveti Vracevi - Novi Kneževac, Serbia
- A Shine S R O - Pilsen, Czechia
- Medical Center Medconsult-Pleven - Pleven, Bulgaria
- Clintrial s r o - Prague, Czechia
- NeuropsychiatrieHK, s.r.o. - Prague, Czechia
- SC Carpe Diem SRL - Sibiu, Romania
- Mental Health Centre Prof. N Shipkovenski EOOD - Sofia, Bulgaria
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD - Sofia, Bulgaria
- Medical Center Hera EOOD - Sofia, Bulgaria
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →