Testing ACP-204 for treating psychosis in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of ACP-204 in adults with Alzheimer's Disease Psychosis (ADP) through three independent substudies. The first substudy will assess the dose response of ACP-204 at 30 and 60 mg compared to a placebo, while the subsequent Phase 3 substudies will confirm the findings using either dose against a placebo. Each substudy includes a screening period, a double-blind treatment phase lasting six weeks, and a safety follow-up period. The trial aims to provide insights into the effectiveness of ACP-204 in managing psychotic symptoms associated with Alzheimer's disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Endpoint LLC
  Scottsdale, Arizona, United States Recruiting
• ATP Clinical Research
  Costa Mesa, California, United States Recruiting
• Neuro-Pain Medical Center
  Fresno, California, United States Recruiting
• Havana Research Institute LLC
  Pasadena, California, United States Recruiting
• Quantum Clinical Research, Inc.
  Pasadena, California, United States Recruiting
• Humanity Clinical Research Corp
  Aventura, Florida, United States Recruiting

+105 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Christine Murphy
• Email: cmurphy@acadia-pharm.com
• Phone: 858-465-7480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.