Alzheimer's Disease Psychosis
Conditions
Keywords
Alzheimer's Disease Psychosis, Hallucinations, Delusions
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.
Interventions
DRUGACP-204
ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No
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 * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score | 52 Weeks |
Countries
Brazil, Bulgaria, Chile, Czechia, France, Italy, Mexico, Serbia, South Korea, Spain, Taiwan, United States
Outcome results
None listed