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ACP-204 in Adults With Alzheimer's Disease Psychosis

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ClinicalTrials.gov Identifier: NCT06159673
Recruitment Status : Recruiting
First Posted : December 7, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Psychosis Drug: ACP-204 Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1074 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ACP-204 30 mg
Administration once daily at approximately the same time of day, with or without food
 Drug: ACP-204
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Experimental: ACP-204 60 mg
Administration once daily at approximately the same time of day, with or without food
 Drug: ACP-204
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo Comparator: Placebo
Administration once daily at approximately the same time of day, with or without food
 Drug: Placebo
ACP-204 matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) [ Time Frame: From baseline to Week 6 ]
    The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.


Secondary Outcome Measures :
  1. Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [ Time Frame: Week 6 ]
    The CGI-I scale is a clinician-rated, 7-point scale used to rate the improvement in symptoms at the time of assessment, relative to the symptoms at Baseline. The CGI-I-ADP scale is the CGI-I scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06159673


Contacts
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Contact: Christine Murphy 858-465-7480 cmurphy@acadia-pharm.com
Contact: Mariana Alvarado 415-265-0796 mariana.alvarado@acadia-pharm.com

Locations
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Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
More Information
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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT06159673    
Other Study ID Numbers: ACP-204-006
First Posted: December 7, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ACADIA Pharmaceuticals Inc.:
Alzheimer's disease psychosis
Hallucinations
Delusions
Additional relevant MeSH terms:
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Alzheimer Disease
Psychotic Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders