Recruiting

NCT Number: NCT06159673

ACP-204 in Adults With Alzheimer's Disease Psychosis

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).

Recruiting

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Key information

Conditions

Alzheimer's Disease Psychosis Behavior Behavioral Symptoms Delusions Hallucinations Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinica Neurologica e Neurocirurgica de Joinville, Joinville, Santa Catarina, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACP-204

Drug

ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

Placebo

Drug

ACP-204 matching placebo

Primary outcomes

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 outcomes

Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score

Time frame: Baseline to Week 6

The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder. The CGI-S-ADP scale is the CGI-S scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Murphy

CONTACT

[email protected]

858-465-7480

Kristen White

CONTACT

[email protected]

813-838-6468

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Dec 7, 2023
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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