Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Part of paid clinical trials in Irvine, California.
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Study ID
- NCT07095465
- Phase
- PHASE3
- Status
- Enrolling By Invitation
Conditions
- Lewy Body Dementia Psychosis
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - 84 Years
- Healthy Volunteers
- Not accepted
Interventions
- ACP-204 — DRUGProvided as 1 capsule, to be taken orally once daily
Study Details
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Key Dates
- Start date
- Nov 14, 2025
- Status verified
- Jul 2025
- Primary completion
- Feb 28, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 126 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ACP-204Initiation 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.
Primary Outcome Measure
Proportion of subjects who experience treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ATP Clinical Research Inc. | Irvine | California | 92612 | - |
| Humanity Clinical Research, Corp | Aventura | Florida | 33180 | - |
| K2 Summit Research | Lady Lake | Florida | 32159 | - |
| Advanced Clinical Research Network, Corp | Miami | Florida | 33135 | - |
| Homestead Associates in Research Inc | Miami | Florida | 33032 | - |
| MediClear Medical & Research Center, Inc. | Miami | Florida | 33165 | - |
| Health Synergy Clinical Research, LLC | West Palm Beach | Florida | 33407 | - |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | - |
| University of Kansas Medical Center Research Institute Inc. | Kansas City | Kansas | 66160 | - |
| The Ohio State University, Energy Advancement and Innovation Center | Columbus | Ohio | 43210 | - |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | - |
| R and H Clinical Research | Stafford | Texas | 77477 | - |
| Virginia Commonwealth University (a public institution of higher education) | Richmond | Virginia | 23219 | - |
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