Phase 2: testing ITI-1284 for Agitation Associated With Alzheimer's Dementia
This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, flexible-dose study of the how well it works, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
Official registry: https://clinicaltrials.gov/study/NCT06651567 · Intra-Cellular Therapies, Inc. · enrollment listed as 320
What this phase means
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, compared with a dummy treatment, flexible-dose study of the how well it works, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
They plan to enroll about 320 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 of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia
Interventions: ITI-1284, Placebo
Primary outcome (registry wording): Cohen-Mansfield Agitation Inventory (CMAI) total score
Who it is for (from inclusion criteria)
- Ages 55 Years to any
- Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
- Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
- Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
- CGI-S score ≥ 4 at Screening and Baseline;
- Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;
Who the registry excludes
- Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
- 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;
- Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
- The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients
Public study contact (from the registry)
Study Contact
Participate-In-This-Study1@its.jnj.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
71 listed- Advanced Research Center, Inc — Anaheim, California (recruiting)
- ATP Clinical Research — Costa Mesa, California (completed)
- National Institute Of Clinical Research — Garden Grove, California (completed)
- Wr Pri Llc — Newport Beach, California (completed)
- Sunwise Clinical Research — Walnut Creek, California (recruiting)
- SFM Clinical Research LLC — Boca Raton, Florida (recruiting)
- Envision Trials LLC — Bonita Springs, Florida (recruiting)
- Clinical Research of Brandon — Brandon, Florida (recruiting)
- Brain Matters Research — Delray Beach, Florida (completed)
- Science Connections LLC — Doral, Florida (recruiting)
- Direct Helpers Medical Center, Inc. — Hialeah, Florida (recruiting)
- Homestead Associates in Research Inc — Homestead, Florida (recruiting)
+ 39 sites outside the US on the same record
FAQ about this NCT record
Is NCT06651567 still recruiting?
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 NCT06651567?
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 NCT06651567?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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