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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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