Tests ITI-1284 for agitation linked to Alzheimer's dementia
Tests ITI-1284 against a placebo in people with agitation from Alzheimer's dementia.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Key facts
- Where
- Anaheim, Boca Raton, Bonita Springs, Boston, Brandon, Costa Mesa, Delray Beach, Doral, Garden Grove, Hialeah, Homestead, Las Vegas, Maitland, Miami, Newport Beach, Orlando, Raleigh, San Antonio, Tampa, Toms River, Walnut Creek, and West Palm Beach, United StatesSee the 32 sites
- Phase
- Phase 2
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- SFM Clinical Research LLCBoca Raton, United StatesTaking people
- Envision Trials LLCBonita Springs, United StatesTaking people
- Tufts University School of MedicineBoston, United StatesTaking people
- Clinical Research of BrandonBrandon, United StatesTaking people
- ATP Clinical ResearchCosta Mesa, United StatesNo longer taking part
- Brain Matters ResearchDelray Beach, United StatesNo longer taking part
- Science Connections LLCDoral, United StatesTaking people
- National Institute Of Clinical ResearchGarden Grove, United StatesNo longer taking part
- Direct Helpers Medical Center, Inc.Hialeah, United StatesTaking people
- Homestead Associates in Research IncHomestead, United StatesTaking people
- Oasis Clinical Research LLCLas Vegas, United StatesTaking people
- K2 Medical ResearchMaitland, United StatesTaking people
- Neurology Associates PAMaitland, United StatesTaking people
- Advanced Clinical Research NetworkMiami, United StatesTaking people
- Allied Biomedical Research Institute (ABRI), IncMiami, United StatesTaking people
- South Florida Research Phase I-IVMiami, United StatesTaking people
- Sunshine Medical Research Studies IncMiami, United StatesTaking people
- Vital Care ResearchMiami, United StatesTaking people
- Wellness Research CenterMiami, United StatesTaking people
- Advance Medical Research CenterMiami, United StatesNo longer taking part
- Miami Jewish Health SystemMiami, United StatesNo longer taking part
- Wr Pri LlcNewport Beach, United StatesNo longer taking part
- Charter ResearchOrlando, United StatesTaking people
- Combined Research OrlandoOrlando, United StatesNo longer taking part
- Eximia Clinical Research NCRaleigh, United StatesNo longer taking part
- UT Health San AntonioSan Antonio, United StatesTaking people
- Psych Me Medical Research IncTampa, United StatesTaking people
- Quantum Research Associates CorpTampa, United StatesTaking people
- Bio Behavioral HealthToms River, United StatesTaking people
- Sunwise Clinical ResearchWalnut Creek, United StatesTaking people
- Premiere Research Institute at Palm Beach NeurologyWest Palm Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Intra-Cellular Therapies, Inc.
- Trial code
- NCT06651567EU 2024-514680-26-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.