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

Alzheimer's Disease Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06194799
• Other study ID #: ACP-204-008
• Secondary ID: Luminous
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 23, 2024
• Est. completion date: May 2029

Study information

• Verified date: May 2024
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 752
• Est. completion date: May 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Abington Neurological Associates	Abington	Pennsylvania
United States	Future Care Solution, LLC	Miami	Florida
United States	Homestead Associates in Research Inc.	Miami	Florida
United States	MediClear Medical & Research Center, Inc.	Miami	Florida
United States	Verus Clinical Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score		52 Weeks