RecruitingAlzheimer's Disease Psychosis

ACP-204 in Adults With Alzheimer's Disease Psychosis

Eligible age

55–95 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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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).

Sponsor: ACADIA Pharmaceuticals Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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