ACP-204 in Adults With Alzheimer's Disease Psychosis

Launched by ACADIA PHARMACEUTICALS INC. · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ACP-204 for adults with Alzheimer's Disease Psychosis (ADP), which involves experiencing confusion or delusions related to Alzheimer's disease. The trial will be conducted at multiple locations and includes three parts. The first part will test two different doses of ACP-204 (30 mg and 60 mg) to see how effective they are compared to a placebo (a pill with no active medication). If the first part shows promising results, the next two parts will further confirm the effectiveness of the doses.

To be eligible for the trial, participants need to be between 55 and 95 years old and must have a diagnosis of Alzheimer's disease with psychotic symptoms lasting at least two months. They also need to have a reliable caregiver to assist them throughout the study. Participants will go through a screening period, followed by six weeks of treatment, and then a safety follow-up to monitor their health. The trial is currently recruiting participants, and those interested should reach out to learn more about joining the study.

Gender

ALL

Eligibility 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:
• • 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
• • 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.