A 52-Week, Open-Label Extension Study of ACP-204 in Adults with Alzheimer's Disease Psychosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507351-29-00

Acronym

ACP-204-008

Enrollment

196

Registered

2024-05-31

Start date

2024-12-03

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease Psychosis

Brief summary

Treatment-emergent adverse events [Time Frame: 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.

Detailed description

Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [Time Frame: 52 Weeks]

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events [Time Frame: 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

Measure	Time frame
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [Time Frame: 52 Weeks]	—

Countries

Bulgaria, Czechia, France, Italy, Spain

Outcome results