ACP-204 in Adults With Alzheimer's Disease Psychosis

Prior treatment

• Requires treatment with a medication prohibited by the protocol
• Is in hospice and receiving end-of-life palliative care, or has become bedridden
• Treatment with anti-tau therapy or donanemab within 2 months prior to Screening
  • Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Other illness

• 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

Lab values

• Protocol-defined exclusionary clinical laboratory findings

Other

• Requires skilled nursing care
• Atrial fibrillation
• Symptomatic orthostatic hypotension

• 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