ACP-204 in Adults With Alzheimer's Disease Psychosis
- Registration Number
- NCT06159673
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1074
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administration once daily at approximately the same time of day, with or without food ACP-204 60 mg ACP-204 Administration once daily at approximately the same time of day, with or without food ACP-204 30 mg ACP-204 Administration once daily at approximately the same time of day, with or without food
- Primary Outcome Measures
Name Time Method Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) From baseline to Week 6 The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score Week 6 The CGI-I scale is a clinician-rated, 7-point scale used to rate the improvement in symptoms at the time of assessment, relative to the symptoms at Baseline. The CGI-I-ADP scale is the CGI-I scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.
Trial Locations
- Locations (132)
Combined Research Orlando Phase I IV
🇺🇸Orlando, Florida, United 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
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
Scroll for more (122 remaining)Combined Research Orlando Phase I IV🇺🇸Orlando, Florida, United States