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Bored Studies
RecruitingPhase 2/Phase 3

ACP-204 in Adults With Alzheimer's Disease Psychosis

ACADIA Pharmaceuticals Inc. · NCT06159673

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–95 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
1074
US sites recruiting
35
Study start
November 14, 2023
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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 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).

Being studied: ACP-204; Placebo

Conditions: Alzheimer's Disease Psychosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Christine Murphy · 858-465-7480 · cmurphy@acadia-pharm.com
  • Kristen White · 813-838-6468 · kristen.white@acadia-pharm.com
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ACP-204 in Adults With Alzheimer's Disease Psychosis (NCT06159673) | Bored Studies