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 Alzheimer's disease psychosis and Lewy body dementia psychosis. It is designed to address psychotic symptoms, such as hallucinations and delusions, in patients with these neurodegenerative conditions. The drug is currently in Phase 3 clinical development and has not been approved for any indication.
ACP-204 targets the 5-HT2A receptor, a serotonin receptor subtype. By acting on 5-HT2A, the drug is designed to modulate serotonin signaling associated with psychotic symptoms. This targeted mechanism distinguishes it from broad-spectrum antipsychotics and is intended to address psychosis in Alzheimer's disease and Lewy body dementia.
ACP-204 is being developed by ACADIA Pharmaceuticals Inc., which trades on the Nasdaq under the ticker ACAD. ACADIA is a biopharmaceutical company focused on central nervous system disorders. The company is advancing ACP-204 through late-stage clinical trials for psychosis associated with Alzheimer's disease and Lewy body dementia.
ACP-204 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The program includes both Phase 2 and Phase 3 studies, with ongoing trials in Alzheimer's disease psychosis and Lewy body dementia psychosis.
ACP-204 is being evaluated in four registered trials. These include NCT06159673, a Phase 2 study in Alzheimer's disease psychosis, and its open-label extension NCT06194799. In Lewy body dementia psychosis, the trials are NCT07029581, a Phase 2 study, and the Phase 3 open-label extension NCT07095465. All four trials are actively recruiting or enrolling by invitation.
The ACP-204 clinical program has a total planned enrollment of 1,826 participants across its trials. The Alzheimer's disease psychosis studies account for 1,826 participants combined, with 1,074 in the Phase 2 trial and 752 in the open-label extension. The Lewy body dementia psychosis trials add 306 participants. All studies enroll adults aged 55 and older.