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ACP-204 in Adults With Alzheimer's Disease Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06159673
Recruitment Status : Recruiting
First Posted : December 7, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE November 27, 2023
First Posted Date  ICMJE December 7, 2023
Last Update Posted Date May 7, 2024
Actual Study Start Date  ICMJE November 14, 2023
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2023)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACP-204 in Adults With Alzheimer's Disease Psychosis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease Psychosis
Intervention  ICMJE
  • Drug: ACP-204
    ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
  • Drug: Placebo
    ACP-204 matching placebo
Study Arms  ICMJE
  • Experimental: ACP-204 30 mg
    Administration once daily at approximately the same time of day, with or without food
    Intervention: Drug: ACP-204
  • Experimental: ACP-204 60 mg
    Administration once daily at approximately the same time of day, with or without food
    Intervention: Drug: ACP-204
  • Placebo Comparator: Placebo
    Administration once daily at approximately the same time of day, with or without food
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2023)		 1074
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2028
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine Murphy 858-465-7480 cmurphy@acadia-pharm.com
Contact: Mariana Alvarado 415-265-0796 mariana.alvarado@acadia-pharm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06159673
Other Study ID Numbers  ICMJE ACP-204-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ACADIA Pharmaceuticals Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ACADIA Pharmaceuticals Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ACADIA Pharmaceuticals Inc.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP