RightFit
RecruitingPhase 2 / Phase 3

ACP-204 in Adults With Alzheimer's Disease Psychosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 95 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ACP-204 against a placebo, a pill with no active drug. It is for adults ages 55 to 95 with Alzheimer's disease and psychosis, which can include seeing or hearing things that are not there or believing things that are not true. Study treatment lasts 6 weeks.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 55 to 95 years old and meet study rules for possible or likely Alzheimer's disease.
  • Meet study rules for psychosis linked to memory and thinking problems, with symptoms for at least 2 months.
  • Have a blood test or other test showing protein buildup and brain changes linked to Alzheimer's disease.
  • Have a past MRI or CT brain scan that fits an Alzheimer's diagnosis.
  • Score 6 to 24 on the MMSE, a test of memory and thinking.
  • Live in a stable place, at home or in a care facility, with no plans to move.
  • Have a study partner or caregiver who can attend all study visits with you.
  • Take a stable dose of a cholinesterase inhibitor or memantine, medicines for Alzheimer's, if you use them.

Who can't join

  • Need a medicine that the study does not allow.
  • Are receiving end-of-life care in hospice, are confined to bed, or need skilled nursing care.
  • Have psychosis mainly caused by sudden confusion, substance abuse, or a medical or mental health condition other than dementia.
  • Have a history of protein buildup in brain blood vessels, epilepsy, a brain or spinal cord tumor, or unexplained fainting.
  • Have atrial fibrillation, a type of irregular heartbeat.
  • Have a drop in blood pressure when standing that causes symptoms.
  • Have lab test results that are not allowed under the study rules.
  • Received anti-tau treatment or donanemab within 2 months before screening. Other study rules also apply and will be checked at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (52)

AZ

CA

FL

GA

IL

LA

MD

MI

MO

NE

NY

OH

PA

TX