The trial is taking place at:
N

New Life Medical Research Center, Inc. | Hialeah, FL

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ACP-204 in Adults With Alzheimer's Disease Psychosis

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Acadia Pharmaceuticals

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Alzheimer's Disease Psychosis

Treatments

Drug: Placebo
Drug: ACP-204

Study type

Interventional

Funder types

Industry

Identifiers

NCT06159673
ACP-204-006

Details and patient eligibility

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).

Enrollment

1,074 estimated patients

Sex

All

Ages

55 to 95 years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,074 participants in 3 patient groups, including a placebo group

ACP-204 30 mg
Experimental group
Description:
Administration once daily at approximately the same time of day, with or without food
Treatment:
Drug: ACP-204
ACP-204 60 mg
Experimental group
Description:
Administration once daily at approximately the same time of day, with or without food
Treatment:
Drug: ACP-204
Placebo
Placebo Comparator group
Description:
Administration once daily at approximately the same time of day, with or without food
Treatment:
Drug: Placebo

Trial contacts and locations

28

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Central trial contact

Christine Murphy; Mariana Alvarado

Data sourced from clinicaltrials.gov

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