Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACP-204 · 4 trials · 2 indications
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.
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
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 | Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed. |
| ACP-204 30 mg | EXPERIMENTAL | ACP-204 dose of 30 mg once daily |
| ACP-204 60 mg | EXPERIMENTAL | ACP-204 dose of 60 mg once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily |
| Name | Type | Description |
|---|---|---|
| ACP-204 | DRUG | Provided as 1 capsule, to be taken orally once daily |
| Placebo | DRUG | Provided as 1 capsule, to be taken orally once daily |
Inclusion Criteria: * The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator * Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study * Can complete all...
ACP-204 is an investigational small molecule being developed for the treatment of psychosis associated with Alzheimer's disease and Lewy body dementia. It is currently in Phase 3 clinical development for these indications.
ACP-204 is being developed by ACADIA Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACAD.
ACP-204 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing for psychosis associated with Alzheimer's disease and Lewy body dementia.
ACP-204 is being studied in several clinical trials. NCT06159673 is a Phase 2 study in Alzheimer's disease psychosis, and NCT06194799 is its open-label extension. NCT07029581 is a Phase 2 study in Lewy body dementia psychosis, with NCT07095465 as its open-label extension.
ACP-204 is a small molecule designed to treat psychosis in Alzheimer's disease and Lewy body dementia. Its specific molecular target has not been disclosed in available information.