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ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT ID: NCT06159673
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2 / Phase 3
Sponsor: ACADIA Pharmaceuticals Inc.
Conditions: Alzheimer's Disease Psychosis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 1074 participants (Estimated).

What is being studied

Drug: ACP-204
Drug: Placebo

Who may be eligible

Ages: 55 Years to 95 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

150 study locations are listed.

Recruiting site status is explicitly provided for 150 locations; 69 are listed as Recruiting.

Countries: Brazil, Bulgaria, Chile, Czechia, France, Italy, Mexico, Serbia, South Korea, Spain, Taiwan, United States

Santa Catarina, Brazil: 1
Czech Republic, Czechia: 2
N.L, Mexico: 1
Nuevo León, Mexico: 1
Arizona, United States: 2
California, United States: 4
Florida, United States: 20
Illinois, United States: 1
Louisiana, United States: 1
Maryland, United States: 1
Michigan, United States: 1
Missouri, United States: 1
Nebraska, United States: 1
New York, United States: 4
Ohio, United States: 2
Pennsylvania, United States: 1
Texas, United States: 9

Sample of listed locations

Clinica Neurologica e Neurocirurgica de Joinville — Joinville, Santa Catarina, 89202-190, Brazil — Recruiting
Hospital Universitario de Brasilia — Brasília, 70840-901, Brazil — Recruiting
L2IP - Instituto de Pesquisas Clínicas Ltda — Brasília, 70200-730, Brazil — Recruiting
CECPAR Centro de Estudos Clinicos do Parana — Curitiba, 80030-310, Brazil — Recruiting
Inst. de Neurologia de Curitiba Hospital Ecoville — Curitiba, 81210-310, Brazil — Recruiting
TrialTech Tecnologia com Pesquisas em Medicamentos — Curitiba, 80240-280, Brazil — Recruiting
Instituto Mederi de Pesquisa e Saude — Passo Fundo, 99010-120, Brazil — Recruiting
Hospital Moinhos de Vento — Porto Alegre, 90035-001, Brazil — Recruiting
Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, 22270-060, Brazil — Recruiting
Facili-Centro Integrado de Psiquiatria — São Bernardo do Campo, 09726-150, Brazil — Recruiting
BR Trials-Ensaios Clinicos e Consultoria — São Paulo, 01236-030, Brazil — Recruiting
Hospital Sao Paulo — São Paulo, 04024-002, Brazil — Recruiting
Santa Paula Hospital Clinical Research Center — São Paulo, 04550-000, Brazil — Recruiting
Psicomed Estudios Medicos — Antofagasta, 1270244, Chile — Recruiting
Biomedica Research Group — Santiago, 7500710, Chile — Recruiting
CIC de la Universidad Catolica CICUC — Santiago, 8330024, Chile — Recruiting
Especialidades Medicas L y S — Santiago, 7560356, Chile — Recruiting
Iecsi S.C. — Monterrey, N.L, 64310, Mexico — Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez — Monterrey, Nuevo León, 64460, Mexico — Recruiting
Hospital Universitario Dr. Gonzalo Valdes Valdes — Coahuila, 25000, Mexico — Recruiting
Clinical Research Institute S.C — Estado de México, 54055, Mexico — Recruiting
B&B Investigaciones Medicas SC — Mazatlán, 82140, Mexico — Recruiting
Health Pharma Professional Research S.A. de C.V. — Mexico City, 03100, Mexico — Recruiting
Mexico Centre for Clinical Research S.A de C.V — Mexico City, 03100, Mexico — Recruiting
Centro Estudios Clínicos y Esp. Médicas SC CECEM — Nuevo León, 64620, Mexico — Recruiting

Study details

Start date: November 14, 2023
Primary completion date: January 1, 2028
Completion date: February 1, 2028
First posted: December 7, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06159673
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06159673 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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