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Clinical Trials in the USA / NCT06159673
Recruiting Phase 2/3

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673 · tracked via the Priya Life Science USA tracker
Sponsor
ACADIA Pharmaceuticals Inc.
Phase
Phase 2/3
Started
2023-11-14
Last updated
2026-08-31

Condition(s) studied

Alzheimer's Disease Psychosis

Investigational drug(s) / intervention(s)

ACP-204Placebo

ACP-204: ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

Placebo: ACP-204 matching placebo

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).

Eligibility

Sex
ALL
Min age
55 Years
Max age
95 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (149)

FacilityCityRegionStatus
Chandler Clinical Trials Chandler Arizona Recruiting
Clinical Endpoint LLC Scottsdale Arizona Recruiting
Advanced Research Center, Inc. Anaheim California Withdrawn
ATP Clinical Research Costa Mesa California Recruiting
Neuro-Pain Medical Center Fresno California Recruiting
National Institute of Clinical Research Garden Grove California Terminated
Humanity Clinical Research Corp Aventura Florida Recruiting
Arrow Clinical Trials Daytona Beach Florida Recruiting
First Excellent Research Group Doral Florida Recruiting
New Life Medical Research Center Inc. Hialeah Florida Recruiting
Reliable Clinical Research LLC. Hialeah Florida Recruiting
Homestead Associates in Research Inc. Miami Florida Recruiting
Premier Clinical Research Institute, Inc. Miami Florida Recruiting
Central Miami Medical Institute Miami Florida Withdrawn
Advanced Clinical Research Network, Corp Miami Florida Recruiting
Verus Clinical Research Miami Florida Recruiting
Future Care Solution, LLC Miami Florida Recruiting
MediClear Medical & Research Center, Inc. Miami Florida Recruiting
ABBA Medical Group LLC Miami Florida Recruiting
Visionary Investigators Network Miami Florida Withdrawn
Quantum Clinical Trials Miami Beach Florida Recruiting
New Med Research Miami Gardens Florida Recruiting
Floridian Neuroscience Institutue Miami Lakes Florida Recruiting
Combined Research Orlando Phase I IV Orlando Florida Recruiting
Psych Me Medical Research Inc Tampa Florida Withdrawn
Neuroscience Research Institute West Palm Beach Florida Recruiting
Revive Research Institute, Inc. Elgin Illinois Withdrawn
Grace Research, LLC Shreveport Louisiana Recruiting
Khan Revive Research Institute Rochester Hills Michigan Withdrawn
Tekton Research, LLC St Louis Missouri Recruiting
Alivation Research, LLC Lincoln Nebraska Withdrawn
Dent Neurologic Institute Amherst New York Withdrawn
Finger Lakes Clinical Research Rochester New York Withdrawn
SUNY Upstate Medical University Syracuse New York Recruiting
Regional Neurological Associates The Bronx New York Withdrawn
Insight Clinical Trials LLC Beachwood Ohio Withdrawn
Valley Medical Research Centerville Ohio Withdrawn
Abington Neurological Associates Abington Pennsylvania Recruiting
Horizon Clinical Research Group Cypress Texas Recruiting
Prolato Clinical Research Center-Patton Houston Texas Recruiting

+ 109 more sites — see the full list on the official registry below.

More ACADIA Pharmaceuticals Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06159673 on ClinicalTrials.gov ↗ ← All trials in the USA