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

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

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Key information

Conditions

Alzheimer's Disease Psychosis Behavior Behavioral Symptoms Delusions Hallucinations Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACP-204

Drug

ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

Primary outcomes

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 outcomes

Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score

Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: Jan 8, 2024
Registry last updated: Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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