Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

ACADIA Pharmaceuticals Inc.

Conditions:

Alzheimer's Disease Psychosis

Eligibility:

All Genders

55-95 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2029

Estimated Enrollment :

752 Patients enrolled

Trial Details

Trial ID

NCT06194799

Start Date

April 23 2024

End Date

May 1 2029

Last Update

January 6 2026

Active Locations (64)

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Page 1 of 16 (64 locations)

1

ATP Clinical Research

Costa Mesa, California, United States, 92626

2

National Institute Of Clinical Research

Garden Grove, California, United States, 92844

3

New Life Medical Research Center

Hialeah, Florida, United States, 33012

4

Reliable Clinical Research LLC

Hialeah, Florida, United States, 33012