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ACP-204 in Adults With Alzheimer's Disease Psychosis
NCT06159673 · View on ClinicalTrials.gov ↗
Study Summary
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ACP-204
Study Locations (20)
Florida
- Humanity Clinical Research Corp — Aventura
- Arrow Clinical Trials — Daytona Beach
- First Excellent Research Group — Doral
- New Life Medical Research Center Inc. — Hialeah
- Reliable Clinical Research LLC. — Hialeah
- Homestead Associates in Research Inc. — Miami
- Premier Clinical Research Institute, Inc. — Miami
- Central Miami Medical Institute — Miami
- Advanced Clinical Research Network, Corp — Miami
- Verus Clinical Research — Miami
- Future Care Solution, LLC — Miami
- MediClear Medical & Research Center, Inc. — Miami
- ABBA Medical Group LLC — Miami
- Visionary Investigators Network — Miami
California
- Advanced Research Center, Inc. — Anaheim
- ATP Clinical Research — Costa Mesa
- Neuro-Pain Medical Center — Fresno
- National Institute of Clinical Research — Garden Grove
Arizona
- Chandler Clinical Trials — Chandler
- Clinical Endpoint LLC — Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,074 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06159673
The ClinicalTrials.gov registry entry for NCT06159673 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,074 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ACADIA Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alzheimer's Disease Psychosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06159673 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06159673 about?
NCT06159673 is a clinical study titled "ACP-204 in Adults With Alzheimer's Disease Psychosis". This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiat...
What is the current status of trial NCT06159673?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,074 participants. The study started on 2023-11-14. Estimated completion is 2028-02.
What conditions does trial NCT06159673 study?
This clinical trial studies the following conditions: Alzheimer's Disease Psychosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06159673?
The interventions under investigation include: Placebo (DRUG), ACP-204 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06159673?
This trial is sponsored by ACADIA Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06159673 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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