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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ITI-1284 for people with Alzheimer's dementia who have agitation, such as restlessness or aggressive behavior. It compares ITI-1284 with a placebo (a treatment with no active drug) to see how well it works and how safe it is.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must give signed consent if you can. If you cannot, a legally allowed person may give consent, and you must agree if able.
  • You must have Alzheimer's disease confirmed by medical criteria and blood, spinal fluid, or brain scan tests for signs of the disease.
  • Your agitation must meet the study's medical definition.
  • Your agitation and aggression score must be at least 4 at both the screening and starting visits.
  • Your overall illness severity score (CGI-S) must be at least 4 at both the screening and starting visits.
  • Your memory and thinking test score (MMSE-2) must be from 6 to 24 at screening.

Who can't join

  • Your agitation is caused by medicines, difficult surroundings, substance abuse, or another active medical or mental health condition.
  • You have schizophrenia, schizoaffective disorder, or another disorder involving loss of touch with reality that is not related to Alzheimer's dementia.
  • You have bipolar disorder.
  • You have major depression, unless it has been stable and treated for at least 8 weeks before screening.
  • The study doctor or a suicide risk test finds a serious risk of suicidal behavior, or the doctor believes you are an immediate danger to yourself or others.
  • You have attempted suicide within the 2 years before screening.
  • You have a known allergy to, or cannot tolerate, ITI-1284, lumateperone, or any of their ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (31)

CA

FL

MA

NC

NJ

NV

TX