NCT06194799Enrolling by invitationPhase 3
ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 752 (estimated)
- First submitted
- 22 Dec 2023
- Start date
- 23 Apr 2024
- Primary completion date
- Apr 2029
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT06194799
- EU CT number
- 2023-507351-29-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 752
- From 23 Apr 2024 to the primary completion date, Apr 2029
- 106 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requires treatment with a medication prohibited by the protocol
- Is in hospice and receiving end-of-life palliative care, or has become bedridden
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 55 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (106)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET Coordinator of this site? Confirm its status | Cherven Bryag | Bulgaria | Recruiting |
| Medical Center Lifemed EOOD Coordinator of this site? Confirm its status | Kirdzhali | Bulgaria | Recruiting |
| Higya–DCC OOD Coordinator of this site? Confirm its status | Pazardzhik | Bulgaria | Recruiting |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Medical Center Spectar Plovdiv EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Center For Mental Health Prof. N. Shipkovenski EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Intermedica Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Umbal - Prof. D-R Stoyan Kirkovich AD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| Hospital Universitario de Brasilia Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Inst de Neurologia de Curitiba Hospital Ecoville Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| TrialTech Tecnologia com Pesquisas em Medicamentos Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| CECPAR Centro de Estudos Clinicos do Parana Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Instituto Mederi de Pesquisa e Saude Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Ruschel Medicina e Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Facili - Centro Integrado de Psiquiatria Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Unknown status |
| BR Trials-Ensaios Clinicos e Consultoria Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Psicomed Estudios Medicos Coordinator of this site? Confirm its status | Antofagasta | Chile | Unknown status |
| CIC de la Universidad Catolica CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Biomedica Research Group Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Especialidades Medicas L y S Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| NEUROHK s r o Coordinator of this site? Confirm its status | Choceň | Czechia | Recruiting |
| Brain-Soultherapy s.r.o. Coordinator of this site? Confirm its status | Kladno | Czechia | Recruiting |
| AD71 s.r.o Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| FORBELI s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Vestra Clinics s.r.o. Coordinator of this site? Confirm its status | Rychnov nad Kněžnou | Czechia | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Complejo Asistencial de Zamora. Hospital Provincial de Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Recruiting |
| Hospital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Pasteur Coordinator of this site? Confirm its status | Colmar Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Fondazione Istituto G. Giglio Di Cafalu Coordinator of this site? Confirm its status | Cefalu' | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| Pia Fondazione Di Culto E Religione Card G Panico Coordinator of this site? Confirm its status | Tricase | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hospital Universitario de Saltillo Coordinator of this site? Confirm its status | Coahuila | Mexico | Unknown status |
| Centro para el Des de la Med y de Asist Med Esp SC Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Neurociencias Estudios Clinicos Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Clinical Research Institute S.C Coordinator of this site? Confirm its status | Estado de México | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Iecsi S.C. Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| BIND Investigaciones S.C. Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Institute of Mental Health Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Special Hospital for Cerebrovascular Diseases Sveti Sava Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Center Dr Dragisa Misovic Dedinje Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Special Hospital for Psychiatric Diseases Coordinator of this site? Confirm its status | Gornja Toponica | Serbia | Unknown status |
| Special Hospital for Psychiatric Diseases Kovin Coordinator of this site? Confirm its status | Kovin | Serbia | Unknown status |
| Petrovic University Clinical Center Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Janjic University Clinical Center Kragujevas Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Jovanovic University Clinical Centre of Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| University Clinical Center NIS Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Kaohsiung Municipal Ta-Tung Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Abington Neurological Associates Coordinator of this site? Confirm its status | Abington | United States | Unknown status |
| Humanity Clinical Research, Corp Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
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| Horizon Clinical Research Group Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
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