Evaluating ITI-1284 for treating agitation in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients experiencing agitation associated with Alzheimer's dementia. The trial consists of three periods: a screening phase lasting up to four weeks, a 12-week double-blind treatment phase where participants receive either ITI-1284 or a placebo, and a 30-day safety follow-up period after treatment. The study will evaluate how well ITI-1284 alleviates agitation symptoms compared to a placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations;
* 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;

Exclusion Criteria:

* 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;
  * Bipolar disorder;
  * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
* Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;
* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.

Where it's running

• Advanced Research Center, Inc
  Anaheim, California, United States Recruiting
• Sunwise Clinical Research
  Walnut Creek, California, United States Recruiting
• SFM Clinical Research LLC
  Boca Raton, Florida, United States Recruiting
• Envision Trials LLC
  Bonita Springs, Florida, United States Recruiting
• Clinical Research of Brandon
  Brandon, Florida, United States Recruiting
• Science Connections LLC
  Doral, Florida, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EXV-802 and EXV-801 to treat agitation in Alzheimer's disease dementia

  This study will test whether two experimental medicines, EXV-802 and EXV-801, can reduce moderate-to-severe agitation in adults aged 55–90 with Alzheimer's disease dementia.

  Recruiting at 45 sites Phase 2/3 Exciva GmbH · Murrieta, California and 48 other locations · NCT07284472

• Evaluating ONO-2020 for agitation in Alzheimer's patients

  This study is testing if a new medication called ONO-2020 can help reduce agitation in people with Alzheimer's disease.

  Recruiting at 36 sites Phase 2 Ono Pharmaceutical Co., Ltd. · Aichi and 38 other locations · NCT06803823

• Using virtual darkness to reduce agitation in dementia patients

  This study is testing if using virtual darkness can help reduce agitation in people with dementia.

  Recruiting University of Bergen · Askøy, Erdal · NCT06451952

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.