Evaluating ITI-1284 for treating psychosis 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, parallel-group, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients experiencing psychosis associated with Alzheimer's Disease. The trial consists of a screening period to determine eligibility, a 6-week double-blind treatment phase where participants receive either ITI-1284 or a placebo, and a 30-day safety follow-up period. The study will evaluate how well ITI-1284 works compared to placebo in alleviating psychotic symptoms in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

   1. 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
   2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
4. 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
5. CGI-S score ≥ 4 at Screening and Baseline
6. 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
7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)

Exclusion Criteria:

1. 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:

   1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia
   2. Bipolar disorder
2. 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 C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening
3. 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
4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
5. The patient is bedridden or has any significant medical condition that is unstable and would either:

   1. Place the patient at undue risk from study drug or undergoing study procedures; or
   2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study
6. The patient is in hospice or end-of-life care

Where it's running

• Advanced Research Center, Inc
  Anaheim, California, United States Recruiting
• Sunwise Clinical Research
  Walnut Creek, California, 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
• Homestead Associates in Research Inc
  Homestead, 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.

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

• Cervical lymphatic surgery to see if it helps people with mild Alzheimer’s

  We’re testing a surgical approach in people with mild Alzheimer’s to see if creating alternative neck lymph drainage routes can affect brain biomarkers and daily function.

  Recruiting at 2 sites Maliszewski Daniel · Gdansk and 1 other locations · NCT07857759

• Small Soteria-inspired unit vs. standard closed ward for acute psychosis

  A randomized or semi-randomized comparison tests whether a small Soteria-style inpatient unit improves outcomes for adults with acute psychosis compared to a conventional closed psychiatric ward.

  Recruiting Jerusalem Mental Health Center · Jerusalem, Jerusalem · NCT07836348

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.