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

Inclusion Criteria:

• Can understand the nature of the trial and protocol requirements and provide signedinformed consent, if in the judgement of the Investigator is deemed competent toprovide 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 appropriateperson (eg, patient's Legally Authorized Representative [LAR]) before the initiationof any study-specific procedures in accordance with local regulations;

• Meets clinical criteria for Alzheimer's disease based on 2011 National Institute ofAging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria andeither:

• Has a high likelihood for amyloid pathology consistent with Alzheimer'sdisease, as confirmed by blood-based biomarker at Screening as detected by anappropriately validated test; or

• Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloidpositron emission tomography (PET) brain scan;

• Meets all criteria for agitation according to the International PsychogeriatricAssociation (IPA) consensus definition

• Has clinically meaningful agitation defined as a NeuropsychiatricInventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screeningand Baseline;

• CGI-S score ≥ 4 at Screening and Baseline;

• Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) scoreof 6 to 24 at Screening;

Exclusion Criteria:

• Agitation symptoms are attributable to concomitant medications, adverseenvironmental conditions, substance abuse, or active medical or psychiatricconditions 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 isnot related to Alzheimer's dementia;

• Bipolar disorder;

• Major depressive disorder, unless it is considered stable and treated for atleast 8 weeks prior to Screening;

• Has a significant risk for suicidal behavior during the course of theirparticipation in the study, or is considered to be an imminent danger to themselvesor others, in the opinion of the investigator, and/or as assessed by ColumbiaSuicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicideattempts 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.