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

April 1, 2024 updated by: ACADIA Pharmaceuticals Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

752

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33165
        • MediClear Medical & Research Center, Inc.
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACP-204
ACP-204 30mg or 60mg
Drug: ACP-204
ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.
52 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACADIA Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-204-008
  • Luminous (Other Identifier: Acadia Pharmacueticals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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