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: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20
• Primary Completion: 2029-04
• Study Completion: 2029-05-01

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
• 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 (50)

Facili - Centro Integrado de Psiquiatria; 🇧🇷 São Bernardo Do Campo, Brazil

Medical Center Lifemed; 🇧🇬 Kardzhali, Bulgaria

Centro para el Des de la Med y de Asist Med Esp SC; 🇲🇽 Culiacán, Sinaloa, Mexico

Hospital Universitario de Saltillo; 🇲🇽 Coahuila, Mexico

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

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

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