ACP-204 in Adults With Alzheimer's Disease Psychosis
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
- Alzheimer's Disease Psychosis
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Enrolment target
- 1,074
- Started
- 14 November 2023
- Main results due
- January 2028
- Study sites
- 150
- Registry updated
- 25 September 2026
Can you take part?
- Ages 55 years to 95 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Study sites(150)
Chandler Clinical Trials
Chandler, Arizona, United States
Recruiting
Clinical Endpoint LLC
Scottsdale, Arizona, United States
Recruiting
Advanced Research Center, Inc.
Anaheim, California, United States
Withdrawn
ATP Clinical Research
Costa Mesa, California, United States
Recruiting
Neuro-Pain Medical Center
Fresno, California, United States
Recruiting
National Institute of Clinical Research
Garden Grove, California, United States
Terminated
Humanity Clinical Research Corp
Aventura, Florida, United States
Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, United States
Recruiting
First Excellent Research Group
Doral, Florida, United States
Recruiting
New Life Medical Research Center Inc.
Hialeah, Florida, United States
Recruiting
Reliable Clinical Research LLC.
Hialeah, Florida, United States
Recruiting
Homestead Associates in Research Inc.
Miami, Florida, United States
Recruiting
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Recruiting
Central Miami Medical Institute
Miami, Florida, United States
Withdrawn
Advanced Clinical Research Network, Corp
Miami, Florida, United States
Recruiting
Verus Clinical Research
Miami, Florida, United States
Recruiting
Future Care Solution, LLC
Miami, Florida, United States
Recruiting
MediClear Medical & Research Center, Inc.
Miami, Florida, United States
Recruiting
ABBA Medical Group LLC
Miami, Florida, United States
Recruiting
Visionary Investigators Network
Miami, Florida, United States
Withdrawn
Quantum Clinical Trials
Miami Beach, Florida, United States
Recruiting
New Med Research
Miami Gardens, Florida, United States
Recruiting
Floridian Neuroscience Institutue
Miami Lakes, Florida, United States
Recruiting
Combined Research Orlando Phase I IV
Orlando, Florida, United States
Recruiting
Psych Me Medical Research Inc
Tampa, Florida, United States
Withdrawn
Neuroscience Research Institute
West Palm Beach, Florida, United States
Recruiting
Revive Research Institute, Inc.
Elgin, Illinois, United States
Withdrawn
Grace Research, LLC
Shreveport, Louisiana, United States
Recruiting
CBH Health LLC, dba CenExcel Gaitherburg
Gaithersburg, Maryland, United States
Recruiting
Khan Revive Research Institute
Rochester Hills, Michigan, United States
Withdrawn
Tekton Research, LLC
St Louis, Missouri, United States
Recruiting
Alivation Research, LLC
Lincoln, Nebraska, United States
Withdrawn
Dent Neurologic Institute
Amherst, New York, United States
Withdrawn
Finger Lakes Clinical Research
Rochester, New York, United States
Withdrawn
SUNY Upstate Medical University
Syracuse, New York, United States
Recruiting
Regional Neurological Associates
The Bronx, New York, United States
Withdrawn
Insight Clinical Trials LLC
Beachwood, Ohio, United States
Withdrawn
Valley Medical Research
Centerville, Ohio, United States
Withdrawn
Abington Neurological Associates
Abington, Pennsylvania, United States
Recruiting
Horizon Clinical Research Group
Cypress, Texas, United States
Recruiting
Prolato Clinical Research Center-Patton
Houston, Texas, United States
Recruiting
University of Texas Health Science Center
Houston, Texas, United States
Terminated
Clinical Trial Network LLC
Houston, Texas, United States
Recruiting
Kaleidoscope Clinical Research
Houston, Texas, United States
Recruiting
Steven South Goldstein MD and Associates
Houston, Texas, United States
Recruiting
World Research Link
Pasadena, Texas, United States
Recruiting
R & H Clinical Research Inc.
Stafford, Texas, United States
Withdrawn
Tranquil Clinical Research
Webster, Texas, United States
Withdrawn
Clinica Neurologica e Neurocirurgica de Joinville
Joinville, Santa Catarina, Brazil
Recruiting
L2IP - Instituto de Pesquisas Clínicas Ltda
Brasília, Brazil
Recruiting
Hospital Universitario de Brasilia
Brasília, Brazil
Recruiting
CECPAR Centro de Estudos Clinicos do Parana
Curitiba, Brazil
Recruiting
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, Brazil
Recruiting
Inst. de Neurologia de Curitiba Hospital Ecoville
Curitiba, Brazil
Recruiting
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Brazil
Recruiting
Hospital Moinhos de Vento
Porto Alegre, Brazil
Recruiting
Nucleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Brazil
Withdrawn
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
Recruiting
Facili-Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
Recruiting
BR Trials-Ensaios Clinicos e Consultoria
São Paulo, Brazil
Recruiting
Showing 60 of 150 sites — filter to narrow it down. 69 of the 150 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06159673. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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