What this study is
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
What's being tested
- ACP-204
Intervention · DRUG
ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule
Study details
- Official title
- A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Alzheimer's Disease Psychosis
- Enrolling
- 752 people
- Starts
- 2024-04-23
- Est. completion
- 2029-05
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 95 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (78)
78 openClinical Endpoints LLC
Scottsdale, Arizona, United States
ATP Clinical Research
Costa Mesa, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
National Institute Of Clinical Research
Garden Grove, California, United States
Humanity Clinical Research, Corp
Aventura, Florida, United States
First Excellent Research
Doral, Florida, United States
New Life Medical Research Center
Hialeah, Florida, United States
Reliable Clinical Research LLC
Hialeah, Florida, United States
Homestead Associates in Research Inc.
Miami, Florida, United States
Premier Clinical Research Institute Inc
Miami, Florida, United States
Advanced Clinical Research
Miami, Florida, United States
Verus Clinical Research
Miami, Florida, United States
Quantum Clinical Trials
Miami, Florida, United States
Future Care Solution, LLC
Miami, Florida, United States
MediClear Medical & Research Center, Inc.
Miami, Florida, United States
ABBA Medical Research LLC
Miami, Florida, United States
New Med Research
Miami Gardens, Florida, United States
Floridian Neuroscience Institute
Miami Lakes, Florida, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Horizon Clinical Research Group
Cypress, Texas, United States
Uni Texas Health Science Center
Houston, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
Kaleidoscope Clinical Research
Houston, Texas, United States
55 sites outside the US
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitario de Brasilia
Brasília, Brazil
CECPAR Centro de Estudos Clinicos do Parana
Curitiba, Brazil
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, Brazil
Inst de Neurologia de Curitiba Hospital Ecoville
Curitiba, Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
Facili - Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil
BR Trials-Ensaios Clinicos e Consultoria
São Paulo, Brazil
ET Dr. Ivo Natsov-AIPSMC in Psychiatry
Cherven Bryag, Bulgaria
DCC Higia
Pazardzhik, Bulgaria
Medical center Medconsult Pleven OOD
Pleven, Bulgaria
Mental Health Centre-Prof. N Shipkovenski EOOD
Sofia, Bulgaria
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia, Bulgaria
UMHAT Alexandrovska EAD
Sofia, Bulgaria
Psicomed Estudios Medicos
Antofagasta, Chile
Biomedica Research Group
Santiago, Chile
Especialidades Medicas L y S
Santiago, Chile
CIC de la Universidad Catolica CICUC
Santiago, Chile
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
BRAIN-SOULTHERAPY s.r.o
Kladno, Czechia
AD71 s.r.o
Prague, Czechia
Clinical s.r.o
Prague, Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia
Hôpital Lariboisière
Paris, France
Hôpital La Grave
Toulouse, France
ASST Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliera Universitaria OO. RR. S
Salerno, Italy
Azienda Ospedaliera Card. G. Panico
Tricase, Italy
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Neuvo Leon, Mexico
Iecsi S.C.
Monterrey, Nuevo León, Mexico
Neurociencias Estudios Clinicos
Culiacán, Sinaloa, Mexico
Centro para el Des de la Med y de Asist Med Esp SC
Culiacán, Sinaloa, Mexico
Hospital Universitario de Saltillo
Coahuila, Mexico
Clinical Research Institute S.C
Estado de México, Mexico
BIND Investigaciones S.C.
San Luis Potosí City, Mexico
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia
Institute of Mental Health
Belgrade, Serbia
Special Hospital for Cerebrovascular Diseases Sveti Sava
Belgrade, Serbia
Special Hospital for Psychiatric Diseases
Gornja Toponica, Serbia
Special Hospital for Psychiatric Diseases Kovin
Kovin, Serbia
Janjic University Clinical Center Kragujevas
Kragujevac, Serbia
Jovanovic University Clinical Centre of Kragujevac
Kragujevac, Serbia
Petrovic University Clinical Center Kragujevac
Kragujevac, Serbia
University Clinical Center Nis
Niš, Serbia
The Catholic University of Korea
Seoul, Republic of Korea, South Korea
Inha University Hospital
Incheon, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Provincial de Zamora
Zamora, Spain
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
E-DA Hospital
Kaohsiung City, Taiwan
Study team
Sponsor
ACADIA Pharmaceuticals Inc.
Study ID ACP-204-008
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.