ACP-204 in Adults with Alzheimer’s Disease Psychosis

Phase 1

Recruiting

• Conditions: Alzheimer Disease psychosis; MedDRA version: 20.0Level: PTClassification code: 10012271Term: Dementia Alzheimer's type Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-507325-42-00
• Lead Sponsor: Acadia Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1074

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified