Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06194799 | ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study | PHASE3 | ENROLLING BY_INVITATION | 752 | — | — | Apr 23, 2024 | May 1, 2029 | Jun 2, 2026 | 71 | United States, Brazil +10 |
| NCT06159673 | ACP-204 in Adults With Alzheimer's Disease Psychosis | PHASE2 | RECRUITING | 1,074 | — | — | Nov 14, 2023 | Feb 1, 2028 | Jun 8, 2026 | 145 | United States, Brazil +10 |
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.
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
| Arm | Type | Description |
|---|---|---|
| ACP-204 | EXPERIMENTAL | ACP-204 30mg or 60mg |
| ACP-204 30 mg | EXPERIMENTAL | Administration once daily at approximately the same time of day, with or without food |
| ACP-204 60 mg | EXPERIMENTAL | Administration once daily at approximately the same time of day, with or without food |
| Placebo | PLACEBO_COMPARATOR | Administration once daily at approximately the same time of day, with or without food |
| Name | Type | Description |
|---|---|---|
| ACP-204 | DRUG | ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule |
| Placebo | DRUG | ACP-204 matching placebo |
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/caregive...