ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
- Registration Number
- NCT06194799
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 752
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ACP-204 ACP-204 ACP-204 30mg or 60mg
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events 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.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score 52 Weeks
Trial Locations
- Locations (46)
Jovanovic University Clinical Centre of Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Nis
🇷🇸Niš, Serbia
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
National Institute Of Clinical Research
🇺🇸Garden Grove, California, United States
New Life Medical Research Center
🇺🇸Hialeah, Florida, United States
Reliable Clinical Research LLC
🇺🇸Hialeah, Florida, United States
Homestead Associates in Research Inc.
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute Inc
🇺🇸Miami, Florida, United States
Advanced Clinical Research
🇺🇸Miami, Florida, United States
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