ACP-204 in Adults With Alzheimer's Disease Psychosis
About this study
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).
- Condition
- Alzheimer's Disease Psychosis
- Tested
- ACP-204, Placebo
- Sponsor
- ACADIA Pharmaceuticals Inc.
Who can join
- Age
- 55 to 95 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 55 years
- Maximum age: 95 years
- Study condition: Alzheimer's Disease Psychosis
- 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 10
- 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
152 sites, 71 recruiting
L2IP - Instituto de Pesquisas Clínicas Ltda
Brasília, Brazil
Hospital Universitario de Brasilia
Brasília, Brazil
CECPAR Centro de Estudos Clinicos do Parana
Curitiba, Brazil
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, Brazil
Inst. de Neurologia de Curitiba Hospital Ecoville
Curitiba, Brazil
Clinica Neurologica e Neurocirurgica de Joinville
Joinville, Santa Catarina, Brazil
and 146 more sites on ClinicalTrials.gov
Contact
-
Christine Murphy
858-465-7480 cmurphy@acadia-pharm.com
-
Kristen White
813-838-6468 kristen.white@acadia-pharm.com
Potential match only. Final eligibility is determined by the study team.