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
2 other identifiers
interventional
752
12 countries
69
Brief Summary
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Longer than P75 for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Start
First participant enrolled
April 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
May 4, 2026
December 1, 2025
4.9 years
December 22, 2023
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
52 Weeks
Secondary Outcomes (1)
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score
52 Weeks
Study Arms (1)
ACP-204
EXPERIMENTALACP-204 30mg or 60mg
Interventions
ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule
Eligibility Criteria
You 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
ATP Clinical Research
Costa Mesa, California, 92626, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
New Life Medical Research Center
Hialeah, Florida, 33012, United States
Reliable Clinical Research LLC
Hialeah, Florida, 33012, United States
Homestead Associates in Research Inc.
Miami, Florida, 33032, United States
Premier Clinical Research Institute Inc
Miami, Florida, 33122, United States
Advanced Clinical Research
Miami, Florida, 33135, United States
Verus Clinical Research
Miami, Florida, 33135, United States
Quantum Clinical Trials
Miami, Florida, 33140, United States
Future Care Solution, LLC
Miami, Florida, 33165, United States
MediClear Medical & Research Center, Inc.
Miami, Florida, 33165, United States
ABBA Medical Research LLC
Miami, Florida, 33176, United States
New Med Research
Miami Gardens, Florida, 33056, United States
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
Uni Texas Health Science Center
Houston, Texas, 77054, United States
Clinical Trial Network LLC
Houston, Texas, 77074, United States
Kaleidoscope Clinical Research
Houston, Texas, 77089, United States
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital Universitario de Brasilia
Brasília, 70840-901, Brazil
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, 80240-280, Brazil
Inst de Neurologia de Curitiba Hospital Ecoville
Curitiba, 81210-310, Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010-120, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060, Brazil
Facili - Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150, Brazil
BR Trials-Ensaios Clinicos e Consultoria
São Paulo, 01236-030, Brazil
ET Dr. Ivo Natsov-AIPSMC in Psychiatry
Cherven Bryag, 5980, Bulgaria
Medical Center Lifemed
Kardzhali, 6600, Bulgaria
DCC Higia
Pazardzhik, 4402, Bulgaria
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
Mental Health Centre-Prof. N Shipkovenski EOOD
Sofia, 1000, Bulgaria
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia, 1408, Bulgaria
UMHAT Alexandrovska EAD
Sofia, 1431, Bulgaria
Psicomed Estudios Medicos
Antofagasta, 1270244, Chile
Biomedica Research Group
Santiago, 7500710, Chile
Especialidades Medicas L y S
Santiago, 7560356, Chile
CIC de la Universidad Catolica CICUC
Santiago, 8330024, Chile
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
BRAIN-SOULTHERAPY s.r.o
Kladno, 27201, Czechia
AD71 s.r.o
Prague, 109 00, Czechia
Clinical s.r.o
Prague, 110 00, Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01, Czechia
Hôpital Lariboisière
Paris, 75010, France
Hôpital La Grave
Toulouse, 31059, France
ASST Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria OO. RR. S
Salerno, 84131, Italy
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Neuvo Leon, 64460, Mexico
Iecsi S.C.
Monterrey, Nuevo León, 64310, Mexico
Neurociencias Estudios Clinicos
Culiacán, Sinaloa, 80020, Mexico
Centro para el Des de la Med y de Asist Med Esp SC
Culiacán, Sinaloa, 80230, Mexico
Hospital Universitario de Saltillo
Coahuila, 25000, Mexico
BIND Investigaciones S.C.
San Luis Potosí City, 78213, Mexico
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, 11000, Serbia
Institute of Mental Health
Belgrade, 11000, Serbia
Special Hospital for Psychiatric Diseases
Gornja Toponica, 18202, Serbia
Janjic University Clinical Center Kragujevas
Kragujevac, 34000, Serbia
Jovanovic University Clinical Centre of Kragujevac
Kragujevac, 34000, Serbia
Petrovic University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
The Catholic University of Korea
Seoul, Republic of Korea, 03312, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Provincial de Zamora
Zamora, 49021, Spain
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, 80145, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
E-DA Hospital
Kaohsiung City, 82445, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 8, 2024
Study Start
April 23, 2024
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
May 4, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share