ACP-204 in Adults With Alzheimer's Disease Psychosis

About the study

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 42 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
MMSE score ≥6 and ≤24
Psychotic symptoms for at least 2 months
Lives in a stable place of residence and there are no plans to change living arrangements
Has a designated study partner/caregiver
Able to complete all study visits with a study partner/caregiver
Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable

EXCLUSION CRITERIA

Exclusion Criteria:

Requires treatment with a medication prohibited by the protocol
Is in hospice and receiving end-of-life palliative care, or has become bedridden
Requires skilled nursing care
Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
Atrial fibrillation
Symptomatic orthostatic hypotension
Protocol-defined exclusionary clinical laboratory findings

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.