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New treatment option for Alzheimer's Disease Psychosis
Official title ACP-204 in Adults With Alzheimer's Disease Psychosis
ClinicalTrials.gov ID: NCT06159673
What this study is testing
What is ACP-204?
ACP-204 is an investigational medicine, being studied as a potential treatment for alzheimer's disease psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 95
You may be able to join if
- 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...
- Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
You likely can't join if
- 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
See the full 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 Additional inclusion/exclusion criteria apply. people will be evaluated at screening to ensure that all criteria for study participation...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Costa Mesa, California, United States
- Fresno, California, United States
- Garden Grove, California, United States
- Aventura, Florida, United States
- Daytona Beach, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Elgin, Illinois, United States
- Shreveport, Louisiana, United States
- Rochester Hills, Michigan, United States
+ 78 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States; Costa Mesa, California, United States; Fresno, California, United States; Garden Grove, California, United States and 92 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.