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 multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, compared with a dummy treatment, flexible-dose study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) in the treatment of psychosis in patients with AD.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
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 ITI-1284, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, compared with a dummy treatment, flexible-dose study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) in the treatment of psychosis in patients with AD.
They plan to enroll about 370 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease
Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:
Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline
CGI-S score ≥ 4 at Screening and Baseline
Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures
Who the registry excludes
Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (for example, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:
Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia
The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee
The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
The patient is bedridden or has any significant medical condition that is unstable and would either:
Place the patient at undue risk from study drug or undergoing study procedures; or
Interfere with the interpretation of safety or how well it works evaluations performed during the course of the study
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 NCT06540833?
Phase 2. 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 NCT06540833?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.