Tests ACP-204 for psychosis in people with Alzheimer's disease
Tests ACP-204 against placebo in adults with Alzheimer's disease psychosis.
Plain-language title generated from the registry record
Registry title: ACP-204 in Adults With Alzheimer's Disease Psychosis
Key facts
- Where
- Abington, Amherst, Anaheim, Atlanta, Aventura, Beachwood, Centerville, Chandler, Costa Mesa, Cypress, Dayton, Daytona Beach, Doral, Elgin, Fresno, Gaithersburg, Garden Grove, Hialeah, Houston, Lincoln, Marlton, Miami, Miami Beach, Miami Gardens, Miami Lakes, Orlando, Pasadena, Rochester, Rochester Hills, Scottsdale, Shreveport, St Louis, Stafford, Syracuse, Tampa, The Bronx, Webster, and West Palm Beach, United StatesSee the 53 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 95 years old?
Source: NCT06159673, who can take part
Where in United States
- Abington Neurological AssociatesAbington, United StatesTaking people
- Dent Neurologic InstituteAmherst, United StatesNo longer taking part
- Advanced Research Center, Inc.Anaheim, United StatesNo longer taking part
- Agile Clinical Research Trials, LLCAtlanta, United StatesTaking people
- Humanity Clinical Research, CorpAventura, United StatesTaking people
- Insight Clinical Trials LLCBeachwood, United StatesNo longer taking part
- Valley Medical ResearchCenterville, United StatesNo longer taking part
- Chandler Clinical TrialsChandler, United StatesNo longer taking part
- ATP Clinical ResearchCosta Mesa, United StatesTaking people
- Horizon Clinical Research GroupCypress, United StatesTaking people
- NDx Clinical Research Inc.Dayton, United StatesTaking people
- Arrow Clinical TrialsDaytona Beach, United StatesTaking people
- First Excellent Research GroupDoral, United StatesTaking people
- Revive Research Institute, Inc.Elgin, United StatesNo longer taking part
- Neuro-Pain Medical CenterFresno, United StatesTaking people
- CBH Health LLC, dba CenExcel GaithersburgGaithersburg, United StatesTaking people
- National Institute Of Clinical ResearchGarden Grove, United StatesNo longer taking part
- New Life Medical Research Center, IncHialeah, United StatesTaking people
- Reliable Clinical Research LLCHialeah, United StatesTaking people
- Clinical Trial Network LLCHouston, United StatesTaking people
- Kaleidoscope Clinical ResearchHouston, United StatesTaking people
- Prolato Clinical Research Center-PattonHouston, United StatesTaking people
- Steven South Goldstein MD and AssociatesHouston, United StatesTaking people
- University of Texas Health Science CenterHouston, United StatesNo longer taking part
- Alivation Research, LLCLincoln, United StatesNo longer taking part
- Advanced Memory Research Institute of New JerseyMarlton, United StatesTaking people
- ABBA Medical Group LLCMiami, United StatesTaking people
- Advanced Clinical Research Network, CorpMiami, United StatesTaking people
- Future Care Solution LLCMiami, United StatesTaking people
- Homestead Associates in Research Inc.Miami, United StatesTaking people
- MediClear Medical & Research Center, Inc.Miami, United StatesTaking people
- Premier Clinical Research Institute IncMiami, United StatesTaking people
- Verus Clinical ResearchMiami, United StatesTaking people
- Central Miami Medical InstituteMiami, United StatesNo longer taking part
- Visionary Investigators NetworkMiami, United StatesNo longer taking part
- Quantum Clinical TrialsMiami Beach, United StatesTaking people
- New Med ResearchMiami Gardens, United StatesTaking people
- Floridian Neuroscience InstitutueMiami Lakes, United StatesTaking people
- Combined Research Orlando Phase I-IVOrlando, United StatesTaking people
- Havana Research Institute LLCPasadena, United StatesTaking people
- Quantum Clinical Research, Inc.Pasadena, United StatesTaking people
- World Research LinkPasadena, United StatesTaking people
- Finger Lakes Clinical ResearchRochester, United StatesNo longer taking part
- Khan Revive Research InstituteRochester Hills, United StatesNo longer taking part
- Clinical Endpoint LLCScottsdale, United StatesTaking people
- Grace Research, LLCShreveport, United StatesTaking people
- Tekton Research LLCSt Louis, United StatesTaking people
- R & H Clinical Research Inc.Stafford, United StatesNo longer taking part
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- Psych Me Medical Research IncTampa, United StatesNo longer taking part
- Regional Neurological AssociatesThe Bronx, United StatesNo longer taking part
- Tranquil Clinical ResearchWebster, United StatesNo longer taking part
- Neuroscience Research InstituteWest Palm Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT06159673EU 2023-507325-42-00
- Record updated
- 5 November 2026
- Original description
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADPRead full original descriptionShow less
A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of 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 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).
Inclusion: Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting; Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria; Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA); Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD; Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD; Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association; MMSE score ≥6 and ≤24; Psychotic symptoms for at least 2 months; Lives in a stable place of residence and there are no plans to change living arrangements; Has a designated study partner/caregiver; Able to complete all study visits with a study partner/caregiver; Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable.
Exclusion: Requires treatment with a medication prohibited by the protocol; Is in hospice and receiving end-of-life palliative care, or has become bedridden; Treatment with anti-tau therapy or donanemab within 2 months prior to Screening; Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met; Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia; Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope; Protocol-defined exclusionary clinical laboratory findings; Requires skilled nursing care; Atrial fibrillation; Symptomatic orthostatic hypotension.