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Alzheimer's Disease Psychosis

ACP-204 in Adults With Alzheimer's Disease Psychosis

Sponsored by ACADIA Pharmaceuticals Inc.

About this trial

Last updated 7 months ago

Study ID

ACP-204-006

Status

Recruiting

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

Yes

Accepting

18-75 Years
55 to 95 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial 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 42 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).

What are the participation requirements?

Yes

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

No

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 Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.