ACP-204 in Adults With Alzheimer's Disease Psychosis
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Alzheimer's Disease Psychosis
In brief
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).
Key facts
- Study ID
- NCT06159673
- Run by
- ACADIA Pharmaceuticals Inc.
- People needed
- 1074
- Starts
- 2023-11-14
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 55 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Requires treatment with a medication prohibited by the protocol
- Is in hospice and receiving end-of-life palliative care, or has become bedridden
- Requires skilled nursing care
- 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
- Atrial fibrillation
- Symptomatic orthostatic hypotension
- Protocol-defined exclusionary clinical laboratory findings
- 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.
Where it is running
- Neuroscience Research Institute — West Palm Beach, Florida, United States (enrolling)
- Abington Neurological Associates — Abington, Pennsylvania, United States (enrolling)
- ATP Clinical Research — Costa Mesa, California, United States (enrolling)
- Clinical Endpoint LLC — Scottsdale, Arizona, United States (enrolling)
- Grace Research, LLC — Shreveport, Louisiana, United States (enrolling)
- Tekton Research, LLC — St Louis, Missouri, United States (enrolling)
- Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
- First Excellent Research Group — Doral, Florida, United States (enrolling)
- Neuro-Pain Medical Center — Fresno, California, United States (enrolling)
- Reliable Clinical Research LLC. — Hialeah, Florida, United States (enrolling)
- Chandler Clinical Trials — Chandler, Arizona, United States (enrolling)
- Premier Clinical Research Institute, Inc. — Miami, Florida, United States (enrolling)
- Humanity Clinical Research Corp — Aventura, Florida, United States (enrolling)
- Advanced Clinical Research Network, Corp — Miami, Florida, United States (enrolling)
- Verus Clinical Research — Miami, Florida, United States (enrolling)
- Future Care Solution, LLC — Miami, Florida, United States (enrolling)
- MediClear Medical & Research Center, Inc. — Miami, Florida, United States (enrolling)
- ABBA Medical Group LLC — Miami, Florida, United States (enrolling)
- New Life Medical Research Center Inc. — Hialeah, Florida, United States (enrolling)
- Quantum Clinical Trials — Miami Beach, Florida, United States (enrolling)
- New Med Research — Miami Gardens, Florida, United States (enrolling)
- Floridian Neuroscience Institutue — Miami Lakes, Florida, United States (enrolling)
- Combined Research Orlando Phase I IV — Orlando, Florida, United States (enrolling)
- Homestead Associates in Research Inc. — Miami, Florida, United States (enrolling)
- Horizon Clinical Research Group — Cypress, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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