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.
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;
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
Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
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;
Parallel
ITI-1284
DrugITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
DrugPlacebo rapidly disintegrating tablet, taken once daily, sublingual administration
Cohen-Mansfield Agitation Inventory (CMAI) total score
The CMAI is a reliable and validated, 29-item caregiver-rating questionnaire to assess agitated behavior in elderly patients. Each item is rated on a 7-point scale of frequency, from "never" (1) to "several times an hour" (7), with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203.
Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)
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