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

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

Phase2; Phase3 Interventional ACADIA Pharmaceuticals Inc. · NCT06159673

This study is testing a new medication called ACP-204 to see if it can help reduce psychotic symptoms in people with Alzheimer's disease.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1074 (estimated)
Ages55 Years to 95 Years
SexAll
SponsorACADIA Pharmaceuticals Inc. Industry-sponsored
Drugs / interventionsdonanemab
Locations145 sites (Chandler, Arizona and 144 other locations)
Trial IDNCT06159673 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55 to 95 with a diagnosis of Alzheimer's disease and documented psychotic symptoms lasting at least two months.

Not a fit: Patients without documented evidence of amyloid plaque deposition or those with severe cognitive impairment (MMSE score <6) may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of psychotic symptoms in Alzheimer's patients, enhancing their quality of life.

How similar studies have performed: Previous studies have shown promise in treating psychosis in Alzheimer's patients, but this specific approach with ACP-204 is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chandler, Arizona and 144 other locations

+95 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer's Disease PsychosisAlzheimer's disease psychosisHallucinationsDelusions
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.