ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study

NCT ID: NCT06194799

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2029-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACP-204

ACP-204 30mg or 60mg

Group Type EXPERIMENTAL

ACP-204

Intervention Type DRUG

ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACP-204

ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ATP Clinical Research

Costa Mesa, California, United States

Site Status

New Life Medical Research Center

Hialeah, Florida, United States

Site Status

Reliable Clinical Research LLC

Hialeah, Florida, United States

Site Status

Homestead Associates in Research Inc.

Miami, Florida, United States

Site Status

Premier Clinical Research Institute Inc

Miami, Florida, United States

Site Status

Advanced Clinical Research

Miami, Florida, United States

Site Status

Verus Clinical Research

Miami, Florida, United States

Site Status

Future Care Solution, LLC

Miami, Florida, United States

Site Status

MediClear Medical & Research Center, Inc.

Miami, Florida, United States

Site Status

ABBA Medical Research LLC

Miami, Florida, United States

Site Status

New Med Research

Miami Gardens, Florida, United States

Site Status

Floridian Neuroscience Institute

Miami Lakes, Florida, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

Uni Texas Health Science Center

Houston, Texas, United States

Site Status

Clinical Trial Network LLC

Houston, Texas, United States

Site Status

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Universitario de Brasilia

Brasília, , Brazil

Site Status

TrialTech Tecnologia com Pesquisas em Medicamentos

Curitiba, , Brazil

Site Status

Inst de Neurologia de Curitiba Hospital Ecoville

Curitiba, , Brazil

Site Status

Instituto Mederi de Pesquisa e Saude

Passo Fundo, , Brazil

Site Status

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, , Brazil

Site Status

Facili - Centro Integrado de Psiquiatria

São Bernardo do Campo, , Brazil

Site Status

BR Trials-Ensaios Clinicos e Consultoria

São Paulo, , Brazil

Site Status

ET Dr. Ivo Natsov-AIPSMC in Psychiatry

Cherven Bryag, , Bulgaria

Site Status

Medical Center Lifemed

Kardzhali, , Bulgaria

Site Status

DCC Higia

Pazardzhik, , Bulgaria

Site Status

Medical center Medconsult Pleven OOD

Pleven, , Bulgaria

Site Status

Mental Health Centre-Prof. N Shipkovenski EOOD

Sofia, , Bulgaria

Site Status

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

Sofia, , Bulgaria

Site Status

UMHAT Alexandrovska EAD

Sofia, , Bulgaria

Site Status

Psicomed Estudios Medicos

Antofagasta, , Chile

Site Status

Biomedica Research Group

Santiago, , Chile

Site Status

Especialidades Medicas L y S

Santiago, , Chile

Site Status

CIC de la Universidad Catolica CICUC

Santiago, , Chile

Site Status

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

BRAIN-SOULTHERAPY s.r.o

Kladno, , Czechia

Site Status

AD71 s.r.o

Prague, , Czechia

Site Status

Clinical s.r.o

Prague, , Czechia

Site Status

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, , Czechia

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hôpital La Grave

Toulouse, , France

Site Status

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status

Azienda Ospedaliera Universitaria OO. RR. S

Salerno, , Italy

Site Status

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Neuvo Leon, Mexico

Site Status

Iecsi S.C.

Monterrey, Nuevo León, Mexico

Site Status

Neurociencias Estudios Clinicos

Culiacán, Sinaloa, Mexico

Site Status

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

Culiacán, Sinaloa, Mexico

Site Status

Hospital Universitario de Saltillo

Coahuila, , Mexico

Site Status

BIND Investigaciones S.C.

San Luis Potosí City, , Mexico

Site Status

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, , Serbia

Site Status

Special Hospital for Psychiatric Diseases

Gornja Toponica, , Serbia

Site Status

Special Hospital for Psychiatric Diseases Kovin

Kovin, , Serbia

Site Status

Jovanovic University Clinical Centre of Kragujevac

Kragujevac, , Serbia

Site Status

Petrovic University Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status

University Clinical Center Nis

Niš, , Serbia

Site Status

The Catholic University of Korea

Seoul, Republic of Korea, South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Provincial de Zamora

Zamora, , Spain

Site Status

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

E-DA Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Luminous

Identifier Type: OTHER

Identifier Source: secondary_id

ACP-204-008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AMP SCZ® Observational Study: PREDICT-DPACC
NCT05905003 ACTIVE_NOT_RECRUITING