Recruiting NCT06159673

ACP-204 in Adults With Alzheimer's Disease Psychosis

Phase II / Phase III Interventional Alzheimer's Disease Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ACP-204, Placebo.
Who it may be relevant to: Registry conditions: Alzheimer's Disease Psychosis. Basic parameters: 55 years — 95 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Brazil, Bulgaria, Chile, Czechia +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

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

Primary outcome measures

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]

Secondary outcome measures (1)

Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score [Time frame: Baseline to Week 6]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 46 centers

Chandler Clinical Trials — Chandler
Clinical Endpoint LLC — Scottsdale
Advanced Research Center, Inc. — Anaheim
ATP Clinical Research — Costa Mesa
Neuro-Pain Medical Center — Fresno
National Institute of Clinical Research — Garden Grove
Humanity Clinical Research Corp — Aventura
Arrow Clinical Trials — Daytona Beach
… and 38 more centers

Brazil · 15 centers

Clinica Neurologica e Neurocirurgica de Joinville — Joinville
L2IP - Instituto de Pesquisas Clínicas Ltda — Brasília
Hospital Universitario de Brasilia — Brasília
CECPAR Centro de Estudos Clinicos do Parana — Curitiba
TrialTech Tecnologia com Pesquisas em Medicamentos — Curitiba
Inst. de Neurologia de Curitiba Hospital Ecoville — Curitiba
Instituto Mederi de Pesquisa e Saude — Passo Fundo
Hospital Moinhos de Vento — Porto Alegre
… and 7 more centers

Serbia · 14 centers