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

Inclusion Criteria:

1. 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;

2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

3. Has a high likelihood for amyloid pathology consistent with AD, as confirmed byblood-based biomarker at Screening; or

4. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker oramyloid positron emission tomography (PET) brain scan;

5. Meets criteria for psychosis in accordance with the International PsychogeriatricAssociation (IPA) provisional consensus definition at Screening and Baseline;

6. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideationitem and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening andBaseline;

7. CGI-S score ≥ 4 at Screening and Baseline;

8. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand andanswer questions and comply with procedures;

9. Has a designated caregiver (eg, relative, housemate, close personal friend, orprofessional caregiver);

Exclusion Criteria:

1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, oranother general-medical condition (eg, hypothyroidism) or has been diagnosed withone or more of the following psychiatric conditions:

2. Schizophrenia, schizoaffective disorder, or other psychotic disorder that isnot related to Alzheimer's dementia;

3. Bipolar disorder;

4. Risk for suicidal behavior during the course of their participation in the study oris considered to be an imminent danger to themselves or others, in the opinion ofthe investigator, and/or as assessed by C-SSRS; or the patient has had 1 or moresuicide attempts within 2 years prior to Screening;

5. The patient is unable or unwilling to discontinue other drugs with knownpsychotropic properties or any non-psychotropic drugs with known or potentiallysignificant central nervous system effects, as reviewed by the Sponsor or designee,

6. The patient is hospitalized or receiving skilled nursing care for any medicalcondition other than dementia

7. The patient is bedridden or has any significant medical condition that is unstableand would either:

8. Place the patient at undue risk from study drug or undergoing study procedures;or

9. Interfere with the interpretation of safety or efficacy evaluations performedduring the course of the study;

10. The patient is in hospice or end-of-life care;