ACP-204 in Adults with Alzheimer's Disease Psychosis

Description

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).

Conditions

Alzheimer's Disease Psychosis

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Study Overview

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Study Details

Study 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).

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

ACP-204 in Adults with Alzheimer's Disease Psychosis

Condition
Alzheimer's Disease Psychosis
Intervention / Treatment

-

Contacts and Locations

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805

Costa Mesa

ATP Clinical Research, Costa Mesa, California, United States, 92626

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Garden Grove

National Institute of Clinical Research, Garden Grove, California, United States, 92844

Daytona Beach

Arrow Clinical Trials, Daytona Beach, Florida, United States, 32117

Hialeah

New Life Medical Research Center Inc., Hialeah, Florida, United States, 33012

Hialeah

Reliable Clinical Research LLC., Hialeah, Florida, United States, 33012

Miami Beach

Quantum Clinical Trials, Miami Beach, Florida, United States, 33140

Miami Lakes

Floridian Neuroscience Institutue, Miami Lakes, Florida, United States, 33016

Miami

Homestead Associates in Research Inc., Miami, Florida, United States, 33032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to 95 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ACADIA Pharmaceuticals Inc.,

Study Record Dates

2028-02