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

Phase 3

• Conditions: Alzheimer's Disease Psychosis
• Interventions: Drug: ACP-204

• Registration Number: NCT06194799
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Study Start: 2024-04-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2029-04
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 752

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
• Female who is pregnant or breastfeeding
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACP-204	ACP-204	ACP-204 30mg or 60mg

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	52 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score	52 Weeks

Trial Locations

Locations (41)

Inst de Neurologia de Curitiba Hospital Ecoville; 🇧🇷 Curitiba, Brazil

Ruschel Medicina e Pesquisa Clínica; 🇧🇷 Rio de Janeiro, Brazil

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

Biomedica Research Group; 🇨🇱 Santiago, Chile

Especialidades Medicas L y S; 🇨🇱 Santiago, Chile

BRAIN-SOULTHERAPY s.r.o; 🇨🇿 Kladno, Czechia

Clinical s.r.o; 🇨🇿 Praha 10, Czechia

AD71 s.r.o; 🇨🇿 Praha, Czechia

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital La Grave; 🇫🇷 Toulouse, France

E-DA Hospital; 🇨🇳 Kaohsiung City, Taiwan

Future Care Solution, LLC; 🇺🇸 Miami, Florida, United States

Reliable Clinical Research LLC; 🇺🇸 Hialeah, Florida, United States

Premier Clinical Research Institute Inc; 🇺🇸 Miami, Florida, United States

ET Dr. Ivo Natsov-AIPSMC in Psychiatry; 🇧🇬 Cherven bryag, Bulgaria

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera Universitaria OO. RR. S; 🇮🇹 Salerno, Italy

ATP Clinical Research; 🇺🇸 Costa Mesa, California, United States

National Institute Of Clinical Research; 🇺🇸 Garden Grove, California, United States

New Life Medical Research Center; 🇺🇸 Hialeah, Florida, United States

Homestead Associates in Research Inc.; 🇺🇸 Miami, Florida, United States

Advanced Clinical Research; 🇺🇸 Miami, Florida, United States

Verus Clinical Research; 🇺🇸 Miami, Florida, United States

MediClear Medical & Research Center, Inc.; 🇺🇸 Miami, Florida, United States

Abington Neurological Associates; 🇺🇸 Abington, Pennsylvania, United States

Uni Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, RS, Brazil

TrialTech Tecnologia com Pesquisas em Medicamentos; 🇧🇷 Curitiba, Brazil

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Iecsi S.C.; 🇲🇽 Monterrey, Nuevo Leon, Mexico

BIND Investigaciones S.C.; 🇲🇽 San Luis Potosí, Mexico

Clinical Center Dr Dragisa Misovic Dedinje; 🇷🇸 Belgrade, Serbia

Kaohsiung Municipal Ta-Tung Hospital; 🇨🇳 Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan