ACP-204 in Adults With Alzheimer's Disease Psychosis

Last updated: May 2, 2025
Sponsor: ACADIA Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Schizotypal Personality Disorder (Spd)

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

ACP-204

Placebo

Clinical Study ID

NCT06159673
ACP-204-006
  • Ages 55-95
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is male or female and ≥55 and ≤95 years of age living in the community or in aninstitutionalized setting

  • Meets clinical criteria for possible or probable AD based on the 2011 NationalInstitute on Aging-Alzheimer Association (NIA-AA) criteria

  • Meets the revised criteria for psychosis in major or mild neurocognitive disorderestablished by the International Psychogeriatrics Association (IPA)

  • Has either blood-based biomarker or documented evidence (e.g. positron emissiontomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition andneuropathologic change consistent with AD

  • Has a prior magnetic resonance imaging or computed tomography scan of the brain thatis consistent with the diagnosis of AD

  • Meets revised criteria for psychosis in major or mild neurocognitive disorder as perInternational 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 livingarrangements

  • 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

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, ora medical or psychiatric condition other than dementia

  • Known history of cerebral amyloid angiopathy, epilepsy, central nervous systemneoplasm, 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 Design

Total Participants: 1074
Treatment Group(s): 2
Primary Treatment: ACP-204
Phase: 2/3
Study Start date:
November 14, 2023
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Hospital Universitario de Brasilia

    Brasília, 70840-901
    Brazil

    Active - Recruiting

  • Inst. de Neurologia de Curitiba Hospital Ecoville

    Curitiba, 81210-310
    Brazil

    Active - Recruiting

  • TrialTech Tecnologia com Pesquisas em Medicamentos

    Curitiba, 80240-280
    Brazil

    Active - Recruiting

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120
    Brazil

    Active - Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001
    Brazil

    Active - Recruiting

  • Nucleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, 90430-001
    Brazil

    Active - Recruiting

  • Ruschel Medicina e Pesquisa Clínica

    Rio De Janeiro, 22270-060
    Brazil

    Active - Recruiting

  • Facili-Centro Integrado de Psiquiatria

    Sao Bernardo do Campo, 09726-150
    Brazil

    Active - Recruiting

  • BR Trials-Ensaios Clinicos e Consultoria

    São Paulo, 01236-030
    Brazil

    Active - Recruiting

  • Hospital Sao Paulo

    São Paulo, 04024-002
    Brazil

    Active - Recruiting

  • Hospital das Clínicas da Faculdade de Medicina USP

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • ET Dr. Ivo Natsov - AIPSMC in Psychiatry

    Cherven Bryag, 5980
    Bulgaria

    Active - Recruiting

  • Medical Center Lifemed

    Kardzhali, 6600
    Bulgaria

    Active - Recruiting

  • DCC "Higia"

    Pazardzhik, 4400
    Bulgaria

    Active - Recruiting

  • Medical center Medconsult Pleven OOD

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Medical center Spectar-Plovdic EOOD

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • DCC St. Vrach and St. St. Kuzma and Damian OOD

    Sofia, 1408
    Bulgaria

    Active - Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Active - Recruiting

  • Medical Center Intermediea

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • Mental Health Centre - Prof. N Shipkovenski EOOD

    Sofia, 1377
    Bulgaria

    Active - Recruiting

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHAT Prof. Dr. St. Kirkovich AD

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • Psicomed Estudios Medicos

    Antofagasta, 1270244
    Chile

    Active - Recruiting

  • Biomedica Research Group

    Santiago, 7500710
    Chile

    Active - Recruiting

  • CIC de la Universidad Catolica CICUC

    Santiago, 8330024
    Chile

    Active - Recruiting

  • Especialidades Medicas L y S

    Santiago, 7560356
    Chile

    Active - Recruiting

  • BRAIN-SOUL THERAPY s.r.o.

    Kladno, Czech Republic 27201
    Czechia

    Active - Recruiting

  • Ad71 S.R.O.

    Praha, Czech Republic 109 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91
    Czechia

    Active - Recruiting

  • NEUROHK s.r.o

    Choceň, 56501
    Czechia

    Active - Recruiting

  • CLINTRIAL s.r.o.

    Praha 10, 100 00
    Czechia

    Active - Recruiting

  • FORBELI s.r.o.

    Praha 6, 160 00
    Czechia

    Active - Recruiting

  • INEP medical s.r.o

    Praha 8, 186 00
    Czechia

    Site Not Available

  • Vestra Clinics s.r.o.

    Rychnov Nad Kněžnou, 516 01
    Czechia

    Active - Recruiting

  • Hopital Neurologique Bron

    Bron, 69677
    France

    Active - Recruiting

  • Centre pour Personnes Âgées

    Colmar, 68000
    France

    Active - Recruiting

  • Hospices Civils de Lyon HCL

    Lyon, 69002
    France

    Active - Recruiting

  • Hopital BROCA

    Paris, 75013
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Hôpital La Grave

    Toulouse CEDEX 9, 31059
    France

    Active - Recruiting

  • CHRU de Tours- Hopital Bretonneau

    Tours Cedex 9, 37044
    France

    Active - Recruiting

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 545000
    France

    Active - Recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • IRCCS Neuromed Istituto Neurologico Mediterraneo

    Isernia, 86077
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00185
    Italy

    Active - Recruiting

  • Fondazione Policlinico Uni Campus Bio-Medico di Roma

    Roma, 00128
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria OO. RR. S.

    Salemo, 84131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria OO. RR. S.

    Salerno, 84131
    Italy

    Active - Recruiting

  • Dipartimento di Neuroscienze Rita Levi Montalcini

    Torino, 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Card. G. Panico

    Tricase, 73039
    Italy

    Active - Recruiting

  • Inha University Hospital

    Jung-gu, Incheon 22332
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon 21565
    Korea, Republic of

    Site Not Available

  • Eunpyeong St. Mary's Hospital

    Eunpyeong-gu, Seoul 03312
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Gangnam-Gu, Seoul 06351
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Iecsi S.C.

    Monterrey, N.L 64310
    Mexico

    Active - Recruiting

  • Mexico Centre for Clinical Research S.A de C.V

    Ciudad de Mexico, 03100
    Mexico

    Active - Recruiting

  • Hospital Universitario Dr. Gonzalo Valdes Valdes

    Coahuila, 25000
    Mexico

    Active - Recruiting

  • Clinical Research Institute S.C

    Estado De Mexico, 54055
    Mexico

    Active - Recruiting

  • BIND Investigaciones S.C.

    San Luis Potosí, 78213
    Mexico

    Active - Recruiting

  • Centro para el Des de la Med y de Asist Med Esp SC

    Sinaloa, 80230
    Mexico

    Active - Recruiting

  • Clinical Hosp Center Dr Dragisa Misovic Dedinje

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Clinical. Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Institute of Mental Health

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Spl. Hosp. for Psychiatric Diseases Kovin

    Kovin, 26220
    Serbia

    Active - Recruiting

  • Janjic University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Jovanovic University Clinical Centre of Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis

    Niš, 18000
    Serbia

    Active - Recruiting

  • Spl. Hosp. for Psychiatric Diseases Sveti Vracevi

    Novi Kneževac, 23330
    Serbia

    Active - Recruiting

  • Gen. Hosp. Dr Radivoj Simonovic

    Sombor, 25000
    Serbia

    Active - Recruiting

  • General Hospital Valjevo

    Valjevo, 14000
    Serbia

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Provincial de Zamora

    Zamora, 49021
    Spain

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • E-DA Hospital

    Kaohsiung City,
    Taiwan

    Active - Recruiting

  • Kaohsiung Municipal Ta-Tung Hospital

    Kaohsiung City, 80145
    Taiwan

    Active - Recruiting

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Active - Recruiting

  • ATP Clinical Research

    Costa Mesa, California 92626
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Active - Recruiting

  • National Institute of Clinical Research

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Arrow Clinical Trials

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • New Life Medical Research Center Inc.

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Reliable Clinical Research LLC.

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Advanced Clinical Research Network, Corp

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Central Miami Medical Institute

    Miami, Florida 33125
    United States

    Site Not Available

  • Future Care Solution, LLC

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Homestead Associates in Research Inc.

    Miami, Florida 33032
    United States

    Active - Recruiting

  • MediClear Medical & Research Center, Inc.

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Premier Clinical Research Institute, Inc.

    Miami, Florida 33122
    United States

    Active - Recruiting

  • Verus Clinical Research

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Quantum Clinical Trials

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Floridian Neuroscience Institutue

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Neuroscience Research Institute

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Revive Research Institute, Inc.

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Khan Revive Research Institute

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Regional Neurological Associates

    Bronx, New York 10466
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Insight Clinical Trials LLC

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Valley Medical Research

    Centerville, Ohio 45459
    United States

    Active - Recruiting

  • Abington Neurological Associates

    Abington, Pennsylvania 19001
    United States

    Active - Recruiting

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Kaleidoscope Clinical Research

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Prolato Clinical Research Center-Patton

    Houston, Texas 77054
    United States

    Active - Recruiting

  • University of Texas Health Science Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • R & H Clinical Research Inc.

    Stafford, Texas 77477
    United States

    Active - Recruiting

  • Tranquil Clinical Research

    Webster, Texas 77598
    United States

    Active - Recruiting

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