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New hope for Alzheimer's psychosis: ACP-204 safety trial expands

NCT ID NCT06194799

Symptom relief Sponsor: ACADIA Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tests the long-term safety of a drug called ACP-204 for people with Alzheimer's disease who also have psychosis (hallucinations or delusions). It lasts 52 weeks and includes 752 adults aged 55 to 95 who already completed a previous study of the same drug. The main goal is to monitor side effects and see if the drug remains safe over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 752 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has successfully completed ACP-204-006 study * Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential * Subject has a designated study partner/caregiver * Subjects are able to complete all study visits with a study partner/caregiver * Signed inform consent form with a caregiver or legal representative 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 * Unstable clinically significant medical condition other than AD * Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

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Conditions

The condition(s) this trial relates to.

Delusions Hallucinations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease psychosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    76 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ABBA Medical Research LLC

    Miami, Florida, 33176, United States

  • AD71 s.r.o

    Prague, 109 00, Czechia

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • ATP Clinical Research

    Costa Mesa, California, 92626, United States

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001, United States

  • Advanced Clinical Research

    Miami, Florida, 33135, United States

  • Azienda Ospedaliera Card. G. Panico

    Tricase, 73039, Italy

  • Azienda Ospedaliera Universitaria OO. RR. S

    Salerno, 84131, Italy

  • BIND Investigaciones S.C.

    San Luis Potosí City, 78213, Mexico

  • BR Trials-Ensaios Clinicos e Consultoria

    São Paulo, 01236-030, Brazil

  • BRAIN-SOULTHERAPY s.r.o

    Kladno, 27201, Czechia

  • Biomedica Research Group

    Santiago, 7500710, Chile

  • CECPAR Centro de Estudos Clinicos do Parana

    Curitiba, 80030-310, Brazil

  • CIC de la Universidad Catolica CICUC

    Santiago, 8330024, Chile

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

    Culiacán, Sinaloa, 80230, Mexico

  • Clinical Center Dr Dragisa Misovic Dedinje

    Belgrade, 11000, Serbia

  • Clinical Research Institute S.C

    Estado de México, 54055, Mexico

  • Clinical Trial Network LLC

    Houston, Texas, 77074, United States

  • Clinical s.r.o

    Prague, 110 00, Czechia

  • DCC Higia

    Pazardzhik, 4402, Bulgaria

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

    Sofia, 1408, Bulgaria

  • E-DA Hospital

    Kaohsiung City, 82445, Taiwan

  • ET Dr. Ivo Natsov-AIPSMC in Psychiatry

    Cherven Bryag, 5980, Bulgaria

  • Especialidades Medicas L y S

    Santiago, 7560356, Chile

  • Facili - Centro Integrado de Psiquiatria

    São Bernardo do Campo, 09726-150, Brazil

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Floridian Neuroscience Institute

    Miami Lakes, Florida, 33016, United States

  • Future Care Solution, LLC

    Miami, Florida, 33165, United States

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Homestead Associates in Research Inc.

    Miami, Florida, 33032, United States

  • Horizon Clinical Research Group

    Cypress, Texas, 77429, United States

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Provincial de Zamora

    Zamora, 49021, Spain

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Neuvo Leon, 64460, Mexico

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Brasilia

    Brasília, 70840-901, Brazil

  • Hospital Universitario de Saltillo

    Coahuila, 25000, Mexico

  • Humanity Clinical Research, Corp

    Aventura, Florida, 33180, United States

  • Hôpital La Grave

    Toulouse, 31059, France

  • Hôpital Lariboisière

    Paris, 75010, France

  • Iecsi S.C.

    Monterrey, Nuevo León, 64310, Mexico

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Inst de Neurologia de Curitiba Hospital Ecoville

    Curitiba, 81210-310, Brazil

  • Institute of Mental Health

    Belgrade, 11000, Serbia

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120, Brazil

  • Janjic University Clinical Center Kragujevas

    Kragujevac, 34000, Serbia

  • Jovanovic University Clinical Centre of Kragujevac

    Kragujevac, 34000, Serbia

  • Kaleidoscope Clinical Research

    Houston, Texas, 77089, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Municipal Ta-Tung Hospital

    Kaohsiung City, 80145, Taiwan

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165, United States

  • Medical center Medconsult Pleven OOD

    Pleven, 5800, Bulgaria

  • Mental Health Centre-Prof. N Shipkovenski EOOD

    Sofia, 1000, Bulgaria

  • National Institute Of Clinical Research

    Garden Grove, California, 92844, United States

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • Neurociencias Estudios Clinicos

    Culiacán, Sinaloa, 80020, Mexico

  • New Life Medical Research Center

    Hialeah, Florida, 33012, United States

  • New Med Research

    Miami Gardens, Florida, 33056, United States

  • Petrovic University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • Premier Clinical Research Institute Inc

    Miami, Florida, 33122, United States

  • Psicomed Estudios Medicos

    Antofagasta, 1270244, Chile

  • Quantum Clinical Trials

    Miami, Florida, 33140, United States

  • Reliable Clinical Research LLC

    Hialeah, Florida, 33012, United States

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060, Brazil

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • Special Hospital for Cerebrovascular Diseases Sveti Sava

    Belgrade, 11000, Serbia

  • Special Hospital for Psychiatric Diseases

    Gornja Toponica, 18202, Serbia

  • Special Hospital for Psychiatric Diseases Kovin

    Kovin, 26220, Serbia

  • The Catholic University of Korea

    Seoul, Republic of Korea, 03312, South Korea

  • TrialTech Tecnologia com Pesquisas em Medicamentos

    Curitiba, 80240-280, Brazil

  • UMHAT Alexandrovska EAD

    Sofia, 1431, Bulgaria

  • Uni Texas Health Science Center

    Houston, Texas, 77054, United States

  • University Clinical Center Nis

    Niš, 18000, Serbia

  • Verus Clinical Research

    Miami, Florida, 33135, United States

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01, Czechia

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Other studies related to the condition(s) this trial covers.