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Alzheimer's Disease PsychosisPhase 3NCT06194799

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

A Phase 3 study testing ACP-204 in people with Alzheimer's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 78 sites in 12 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 55 to 95 years
Conditions the study is for
Alzheimer's Disease Psychosis
What is being tested?
ACP-204
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
752 participants
Where
78 sitesin 12 countries
Study dates
23 Apr 2024to May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

78 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

78 sites in 12 countries

United States23 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Humanity Clinical Research, Corp

    Aventura, Florida, 33180

  • ATP Clinical Research

    Costa Mesa, California, 92626

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • First Excellent Research

    Doral, Florida, 33178

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • National Institute Of Clinical Research

    Garden Grove, California, 92844

  • New Life Medical Research Center

    Hialeah, Florida, 33012

  • Reliable Clinical Research LLC

    Hialeah, Florida, 33012

  • Uni Texas Health Science Center

    Houston, Texas, 77054

  • Clinical Trial Network LLC

    Houston, Texas, 77074

  • Kaleidoscope Clinical Research

    Houston, Texas, 77089

  • Homestead Associates in Research Inc.

    Miami, Florida, 33032

  • Premier Clinical Research Institute Inc

    Miami, Florida, 33122

  • Advanced Clinical Research

    Miami, Florida, 33135

  • Verus Clinical Research

    Miami, Florida, 33135

  • Quantum Clinical Trials

    Miami, Florida, 33140

  • Future Care Solution, LLC

    Miami, Florida, 33165

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165

  • ABBA Medical Research LLC

    Miami, Florida, 33176

  • New Med Research

    Miami Gardens, Florida, 33056

  • Floridian Neuroscience Institute

    Miami Lakes, Florida, 33016

  • Clinical Endpoints LLC

    Scottsdale, Arizona, 85258

Other trials in United States

Brazil9 sites

  • Hospital Universitario de Brasilia

    Brasília, 70840-901

  • CECPAR Centro de Estudos Clinicos do Parana

    Curitiba, 80030-310

  • TrialTech Tecnologia com Pesquisas em Medicamentos

    Curitiba, 80240-280

  • Inst de Neurologia de Curitiba Hospital Ecoville

    Curitiba, 81210-310

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

  • Facili - Centro Integrado de Psiquiatria

    São Bernardo do Campo, 09726-150

  • BR Trials-Ensaios Clinicos e Consultoria

    São Paulo, 01236-030

Other trials in Brazil

Serbia9 sites

  • Clinical Center Dr Dragisa Misovic Dedinje

    Belgrade, 11000

  • Institute of Mental Health

    Belgrade, 11000

  • Special Hospital for Cerebrovascular Diseases Sveti Sava

    Belgrade, 11000

  • Special Hospital for Psychiatric Diseases

    Gornja Toponica, 18202

  • Special Hospital for Psychiatric Diseases Kovin

    Kovin, 26220

  • Janjic University Clinical Center Kragujevas

    Kragujevac, 34000

  • Jovanovic University Clinical Centre of Kragujevac

    Kragujevac, 34000

  • Petrovic University Clinical Center Kragujevac

    Kragujevac, 34000

  • University Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Mexico7 sites

  • Hospital Universitario de Saltillo

    Coahuila, 25000

  • Neurociencias Estudios Clinicos

    Culiacán, Sinaloa, 80020

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

    Culiacán, Sinaloa, 80230

  • Clinical Research Institute S.C

    Estado de México, 54055

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Neuvo Leon, 64460

  • Iecsi S.C.

    Monterrey, Nuevo León, 64310

  • BIND Investigaciones S.C.

    San Luis Potosí City, 78213

Other trials in Mexico

Bulgaria6 sites

  • ET Dr. Ivo Natsov-AIPSMC in Psychiatry

    Cherven Bryag, 5980

  • DCC Higia

    Pazardzhik, 4402

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • Mental Health Centre-Prof. N Shipkovenski EOOD

    Sofia, 1000

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

    Sofia, 1408

  • UMHAT Alexandrovska EAD

    Sofia, 1431

Other trials in Bulgaria

Czechia5 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • BRAIN-SOULTHERAPY s.r.o

    Kladno, 27201

  • AD71 s.r.o

    Prague, 109 00

  • Clinical s.r.o

    Prague, 110 00

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

South Korea5 sites

  • Inha University Hospital

    Incheon, 22332

  • The Catholic University of Korea

    Seoul, Republic of Korea, 03312

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Samsung Medical Center

    Seoul, 06351

  • Seoul National University Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

Chile4 sites

  • Psicomed Estudios Medicos

    Antofagasta, 1270244

  • Biomedica Research Group

    Santiago, 7500710

  • Especialidades Medicas L y S

    Santiago, 7560356

  • CIC de la Universidad Catolica CICUC

    Santiago, 8330024

Other trials in Chile

Italy3 sites

  • ASST Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Universitaria OO. RR. S

    Salerno, 84131

  • Azienda Ospedaliera Card. G. Panico

    Tricase, 73039

Other trials in Italy

Taiwan3 sites

  • Kaohsiung Municipal Ta-Tung Hospital

    Kaohsiung City, 80145

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • E-DA Hospital

    Kaohsiung City, 82445

Other trials in Taiwan

France2 sites

  • Hôpital Lariboisière

    Paris, 75010

  • Hôpital La Grave

    Toulouse, 31059

Other trials in France

Spain2 sites

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Provincial de Zamora

    Zamora, 49021

Other trials in Spain

About this study

Official title: A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis

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

Being tested
ACP-204
Keywords
Alzheimer's Disease Psychosis, Hallucinations, Delusions
Medical subject headings
Hallucinations, Delusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACP-204Drug

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

Study groups in NCT06194799
Study groupRoleWhat they receive
ACP-204ExperimentalACP-204 30mg or 60mg
Receives: Drug: ACP-204

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-emergent adverse events

    Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.

    Measured: 52 Weeks

Secondary outcomes (1)

  1. Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start23 Apr 2024
  3. Primary completionApr 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
752 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194799
Sponsor's protocol ID
ACP-204-008
Other IDs
Luminous
Status last verified
Nov 2026
First submitted
22 Dec 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ACP-204 in people with Alzheimer's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 78 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Brazil, Serbia, Mexico, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06194799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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