Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo). * 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 dummy treatment (placebo).
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ACP-204, or Placebo. The registry lists allocation as randomized. This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo).
They plan to enroll about 1,074 people at 155 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: ACP-204, Placebo
Primary outcome (registry wording): Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
Who it is for (from inclusion criteria)
Ages 55 Years to 95 Years
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
Who the registry excludes
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
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06159673?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06159673?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.