ACP-204 in Adults With Alzheimer's Disease Psychosis
Recruiting · NCT06159673 · Interventional (participants receive a specific treatment) · Lead sponsor: ACADIA Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ACP-204Placebo
What this trial is about
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).
Who can take part
Age range
55 Years to 95 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 12 US states.
- Chandler Clinical Trials - Chandler, Arizona, United States
- Clinical Endpoint LLC - Scottsdale, Arizona, United States
- Advanced Research Center, Inc. - Anaheim, California, United States
- ATP Clinical Research - Costa Mesa, California, United States
- Neuro-Pain Medical Center - Fresno, California, United States
- National Institute of Clinical Research - Garden Grove, California, United States
- Humanity Clinical Research Corp - Aventura, Florida, United States
- Arrow Clinical Trials - Daytona Beach, Florida, United States
- First Excellent Research Group - Doral, Florida, United States
- New Life Medical Research Center Inc. - Hialeah, Florida, United States
- Reliable Clinical Research LLC. - Hialeah, Florida, United States
- Homestead Associates in Research Inc. - Miami, Florida, United States
- Premier Clinical Research Institute, Inc. - Miami, Florida, United States
- Central Miami Medical Institute - Miami, Florida, United States
- Advanced Clinical Research Network, Corp - Miami, Florida, United States
- Verus Clinical Research - Miami, Florida, United States
- Future Care Solution, LLC - Miami, Florida, United States
- MediClear Medical & Research Center, Inc. - Miami, Florida, United States
- ABBA Medical Group LLC - Miami, Florida, United States
- Visionary Investigators Network - Miami, Florida, United States
- Quantum Clinical Trials - Miami Beach, Florida, United States
- New Med Research - Miami Gardens, Florida, United States
- Floridian Neuroscience Institutue - Miami Lakes, Florida, United States
- Combined Research Orlando Phase I IV - Orlando, Florida, United States
- Psych Me Medical Research Inc - Tampa, Florida, United States
- Neuroscience Research Institute - West Palm Beach, Florida, United States
- Revive Research Institute, Inc. - Elgin, Illinois, United States
- Grace Research, LLC - Shreveport, Louisiana, United States
- Khan Revive Research Institute - Rochester Hills, Michigan, United States
- Tekton Research, LLC - St Louis, Missouri, United States
- Alivation Research, LLC - Lincoln, Nebraska, United States
- Dent Neurologic Institute - Amherst, New York, United States
- Finger Lakes Clinical Research - Rochester, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- Regional Neurological Associates - The Bronx, New York, United States
- Insight Clinical Trials LLC - Beachwood, Ohio, United States
- Valley Medical Research - Centerville, Ohio, United States
- Abington Neurological Associates - Abington, Pennsylvania, United States
- Horizon Clinical Research Group - Cypress, Texas, United States
- Prolato Clinical Research Center-Patton - Houston, Texas, United States
- University of Texas Health Science Center - Houston, Texas, United States
- Clinical Trial Network LLC - Houston, Texas, United States
- Kaleidoscope Clinical Research - Houston, Texas, United States
- Steven South Goldstein MD and Associates - Houston, Texas, United States
- World Research Link - Pasadena, Texas, United States
- R & H Clinical Research Inc. - Stafford, Texas, United States
- Tranquil Clinical Research - Webster, Texas, United States
- Psicomed Estudios Medicos - Antofagasta, Chile
- Clinical Hosp Center Dr Dragisa Misovic Dedinje - Belgrade, Serbia
- Clinical. Hospital Center Zvezdara - Belgrade, Serbia
- Institute of Mental Health - Belgrade, Serbia
- Special Hospital for Cerebrovascular Disease Sveti Sava - Belgrade, Serbia
- University Clinic Centre of Serbia - Belgrade, Serbia
- L2IP - Instituto de Pesquisas Clínicas Ltda - Brasília, Brazil
- Hospital Universitario de Brasilia - Brasília, Brazil
- ASST degli Spedali Civili di Brescia - Brescia, Italy
- Fakultni nemocnice u sv. Anny v Brne - Brno, Czechia
- Hopital Neurologique Bron - Bron, France
- Neurologia-Fondazione Instituto G. Giglio - Cefalù, Italy
- ET Dr. Ivo Natsov - AIPSMC in Psychiatry - Cherven Bryag, Bulgaria
Showing 60 of 149 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →