A Master Protocol for Three, Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled, Efficacy and Safety Studies of ACP-204 in Adults with Alzheimer's Disease Psychosis

Acadia Pharmaceuticals Inc.0 个研究点目标入组 1,074 人开始时间: 2024年2月8日最近更新: 2024年8月21日

适应症

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•Is male or female and =55 and <85 years of age living in the community or in an institutionalized setting., Able to complete all study visits with a study partner/caregiver, Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable, 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, 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

•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.

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