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

• Status: Enrolling by invitation
• Trial end date: 2029-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Criteria

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.