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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

ACP-204 in Adults With Alzheimer's Disease Psychosis

Sponsor: ACADIA Pharmaceuticals Inc. • ClinicalTrials.gov ID: NCT06159673

Registry updated: 2026-10-19
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Description

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).

Interventions

  • ACP-204 (Drug)
    ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
  • Placebo (Drug)
    ACP-204 matching placebo

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.

Conditions

Alzheimer's Disease Psychosis

Locations

  • Chandler Clinical Trials — Chandler, Arizona, United States
  • Clinical Endpoint LLC — Scottsdale, Arizona, United States
  • Advanced Research Center, Inc. — Anaheim, California, United States
  • ATP Clinical Research — Costa Mesa, California, United States
  • Neuro-Pain Medical Center — Fresno, California, United States
  • National Institute of Clinical Research — Garden Grove, California, United States
  • Havana Research Institute LLC — Pasadena, California, United States
  • Quantum Clinical Research, Inc. — Pasadena, California, United States
  • Humanity Clinical Research Corp — Aventura, Florida, United States
  • Arrow Clinical Trials — Daytona Beach, Florida, United States
  • First Excellent Research Group — Doral, Florida, United States
  • New Life Medical Research Center Inc. — Hialeah, Florida, United States
  • Reliable Clinical Research LLC. — Hialeah, Florida, United States
  • Homestead Associates in Research Inc. — Miami, Florida, United States
  • Premier Clinical Research Institute, Inc. — Miami, Florida, United States
  • Central Miami Medical Institute — Miami, Florida, United States
  • Advanced Clinical Research Network, Corp — Miami, Florida, United States
  • Verus Clinical Research — Miami, Florida, United States
  • Future Care Solution, LLC — Miami, Florida, United States
  • MediClear Medical & Research Center, Inc. — Miami, Florida, United States
  • ABBA Medical Group LLC — Miami, Florida, United States
  • Visionary Investigators Network — Miami, Florida, United States
  • Quantum Clinical Trials — Miami Beach, Florida, United States
  • New Med Research — Miami Gardens, Florida, United States
  • Floridian Neuroscience Institutue — Miami Lakes, Florida, United States
  • Combined Research Orlando Phase I IV — Orlando, Florida, United States
  • Psych Me Medical Research Inc — Tampa, Florida, United States
  • Neuroscience Research Institute — West Palm Beach, Florida, United States
  • Agile Clinical Research Trials LLC — Atlanta, Georgia, United States
  • Revive Research Institute, Inc. — Elgin, Illinois, United States
  • Grace Research, LLC — Shreveport, Louisiana, United States
  • CBH Health LLC, dba CenExcel Gaithersburg — Gaithersburg, Maryland, United States
  • Khan Revive Research Institute — Rochester Hills, Michigan, United States
  • Tekton Research, LLC — St Louis, Missouri, United States
  • Alivation Research, LLC — Lincoln, Nebraska, United States
  • Dent Neurologic Institute — Amherst, New York, United States
  • Finger Lakes Clinical Research — Rochester, New York, United States
  • SUNY Upstate Medical University — Syracuse, New York, United States
  • Regional Neurological Associates — The Bronx, New York, United States
  • Insight Clinical Trials LLC — Beachwood, Ohio, United States
  • Valley Medical Research — Centerville, Ohio, United States
  • NDx Clinical Research Inc. — Dayton, Ohio, United States
  • Abington Neurological Associates — Abington, Pennsylvania, United States
  • Horizon Clinical Research Group — Cypress, Texas, United States
  • Prolato Clinical Research Center-Patton — Houston, Texas, United States
  • University of Texas Health Science Center — Houston, Texas, United States
  • Clinical Trial Network LLC — Houston, Texas, United States
  • Kaleidoscope Clinical Research — Houston, Texas, United States
  • Steven South Goldstein MD and Associates — Houston, Texas, United States
  • World Research Link — Pasadena, Texas, United States
  • R & H Clinical Research Inc. — Stafford, Texas, United States
  • Tranquil Clinical Research — Webster, Texas, United States
  • Clinica Neurologica e Neurocirurgica de Joinville — Joinville, Santa Catarina, Brazil
  • L2IP - Instituto de Pesquisas Clínicas Ltda — Brasília, Brazil
  • Hospital Universitario de Brasilia — Brasília, Brazil
  • CECPAR Centro de Estudos Clinicos do Parana — Curitiba, Brazil
  • TrialTech Tecnologia com Pesquisas em Medicamentos — Curitiba, Brazil
  • Inst. de Neurologia de Curitiba Hospital Ecoville — Curitiba, Brazil
  • Instituto Mederi de Pesquisa e Saude — Passo Fundo, Brazil
  • Hospital Moinhos de Vento — Porto Alegre, Brazil
  • Nucleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre, Brazil
  • Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, Brazil
  • Facili-Centro Integrado de Psiquiatria — São Bernardo do Campo, Brazil
  • BR Trials-Ensaios Clinicos e Consultoria — São Paulo, Brazil
  • Hospital Sao Paulo — São Paulo, Brazil
  • Santa Paula Hospital Clinical Research Center — São Paulo, Brazil
  • Hospital das Clínicas da Faculdade de Medicina USP — São Paulo, Brazil
  • ET Dr. Ivo Natsov - AIPSMC in Psychiatry — Cherven Bryag, Bulgaria
  • Medical Center Lifemed — Kardzhali, Bulgaria
  • DCC "Higia" — Pazardzhik, Bulgaria
  • Medical center Medconsult Pleven OOD — Pleven, Bulgaria
  • UMHAT Sv. Georgi EAD — Plovdiv, Bulgaria
  • Medical center Spectar-Plovdic EOOD — Plovdiv, Bulgaria
  • Mental Health Centre - Prof. N Shipkovenski EOOD — Sofia, Bulgaria
  • DCC St. Vrach and St. St. Kuzma and Damian OOD — Sofia, Bulgaria
  • UMHAT "Alexandrovska" EAD — Sofia, Bulgaria
  • UMHAT Alexandrovska EAD — Sofia, Bulgaria
  • Medical Center Hera EOOD — Sofia, Bulgaria
  • Medical Center Intermedica — Sofia, Bulgaria
  • UMHAT Prof. Dr. St. Kirkovich AD — Stara Zagora, Bulgaria
  • Psicomed Estudios Medicos — Antofagasta, Chile
  • Biomedica Research Group — Santiago, Chile
  • Especialidades Medicas L y S — Santiago, Chile
  • CIC de la Universidad Catolica CICUC — Santiago, Chile
  • BRAIN-SOUL THERAPY s.r.o. — Kladno, Czech Republic, Czechia
  • Ad71 S.R.O. — Prague, Czech Republic, Czechia
  • Fakultni nemocnice u sv. Anny v Brne — Brno, Czechia
  • NEUROHK s.r.o — Choceň, Czechia
  • CLINTRIAL s.r.o. — Prague, Czechia
  • FORBELI s.r.o. — Prague, Czechia
  • INEP medical s.r.o — Prague, Czechia
  • Vestra Clinics s.r.o. — Rychnov nad Kněžnou, Czechia
  • Hopital Neurologique Bron — Bron, France
  • Centre pour Personnes Âgées — Colmar, France
  • Centre Memoire Ressources Recherche CMRR — Dijon, France
  • CHU de Limoges-Hopital Dupuytren — Limoges, France
  • Hospices Civils de Lyon HCL — Lyon, France
  • Hôpital Lariboisière — Paris, France
  • Hopital BROCA — Paris, France
  • CHU Rouen-Hospital Charles Nicolle — Rouen, France
  • Hopital Purpan — Toulouse, France
  • Hôpital La Grave — Toulouse, France
  • CHRU de Tours- Hopital Bretonneau — Tours, France
  • Hôpital de Brabois Adultes — Vandœuvre-lès-Nancy, France
  • ASST degli Spedali Civili di Brescia — Brescia, Italy
  • Neurologia-Fondazione Instituto G. Giglio — Cefalù, Italy
  • IRCCS Neuromed Istituto Neurologico Mediterraneo — Isernia, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Fondazione Policlinico Uni Campus Bio-Medico di Roma — Roma, Italy
  • Policlinico Universitario Agostino Gemelli — Roma, Italy
  • AOU Policlinico Umberto I — Roma, Italy
  • Azienda Ospedaliera Universitaria OO. RR. S. — Salerno, Italy
  • Dipartimento di Neuroscienze Rita Levi Montalcini — Torino, Italy
  • Azienda Ospedaliera Card. G. Panico — Tricase, Italy
  • Iecsi S.C. — Monterrey, N.L, Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez — Monterrey, Nuevo León, Mexico
  • Hospital Universitario Dr. Gonzalo Valdes Valdes — Coahuila, Mexico
  • Clinical Research Institute S.C — Estado de México, Mexico
  • B&B Investigaciones Medicas SC — Mazatlán, Mexico
  • Health Pharma Professional Research S.A. de C.V. — Mexico City, Mexico
  • Mexico Centre for Clinical Research S.A de C.V — Mexico City, Mexico
  • Centro Estudios Clínicos y Esp. Médicas SC CECEM — Nuevo León, Mexico
  • BIND Investigaciones S.C. — San Luis Potosí City, Mexico
  • Neurociencias Estudios Clinicos — Sinaloa, Mexico
  • Centro para el Des de la Med y de Asist Med Esp SC — Sinaloa, Mexico
  • Clinical Hosp Center Dr Dragisa Misovic Dedinje — Belgrade, Serbia
  • Clinical. Hospital Center Zvezdara — Belgrade, Serbia
  • Institute of Mental Health — Belgrade, Serbia
  • Special Hospital for Cerebrovascular Disease Sveti Sava — Belgrade, Serbia
  • University Clinic Centre of Serbia — Belgrade, Serbia
  • Special Hospital for Psychiatric Diseases — Gornja Toponica, Serbia
  • Spl. Hosp. for Psychiatric Diseases Kovin — Kovin, Serbia
  • Janjic University Clinical Center Kragujevac — Kragujevac, Serbia
  • Jovanovic University Clinical Centre of Kragujevac — Kragujevac, Serbia
  • University Clinical Center Kragujevac — Kragujevac, Serbia
  • University Clinical Center Nis — Niš, Serbia
  • Spl. Hosp. for Psychiatric Diseases Sveti Vracevi — Novi Kneževac, Serbia
  • Gen. Hosp. Dr Radivoj Simonovic — Sombor, Serbia
  • General Hospital Valjevo — Valjevo, Serbia
  • Gachon University Gil Medical Center — Incheon, South Korea
  • Inha University Hospital — Incheon, South Korea
  • Korea University Anam Hospital — Seoul, South Korea
  • Eunpyeong St. Mary's Hospital — Seoul, South Korea
  • Hanyang University Seoul Hospital — Seoul, South Korea
  • Konkuk University Medical Center — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • SMG-SNU Boramae Medical Center — Seoul, South Korea
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • Hospital Provincial de Zamora — Zamora, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • E-DA Hospital — Kaohsiung City, Taiwan
  • Taipei Medical University-Shuang Ho Hospital — New Taipei City, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record