A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Agitation Associated With Alzheimer's Dementia

In brief

This is 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

Key facts

Study ID

NCT06651567

Run by

Intra-Cellular Therapies, Inc.

People needed

320

Starts

2024-10-22

Expected to finish

2027-12-28

Last updated by the study team

2026-07-31

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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; 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;

You may not qualify if…

• 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 is running

• Oasis Clinical Research LLC — Las Vegas, Nevada, United States (enrolling)
• Bio Behavioral Health — Toms River, New Jersey, United States (enrolling)
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States (enrolling)
• Tufts University School of Medicine — Boston, Massachusetts, United States (enrolling)
• Envision Trials LLC — Bonita Springs, Florida, United States (enrolling)
• Advanced Research Center, Inc — Anaheim, California, United States (enrolling)
• ATP Clinical Research — Costa Mesa, California, United States (enrolling)
• Science Connections LLC — Doral, Florida, United States (enrolling)
• Direct Helpers Medical Center, Inc. — Hialeah, Florida, United States (enrolling)
• SFM Clinical Research LLC — Boca Raton, Florida, United States (enrolling)
• K2 Medical Research — Maitland, Florida, United States (enrolling)
• Neurology Associates PA — Maitland, Florida, United States (enrolling)
• Vital Care Research — Miami, Florida, United States (enrolling)
• Clinical Research of Brandon — Brandon, Florida, United States (enrolling)
• Advanced Clinical Research Network — Miami, Florida, United States (enrolling)
• Wellness Research Center — Miami, Florida, United States (enrolling)
• Allied Biomedical Research Institute (ABRI), Inc — Miami, Florida, United States (enrolling)
• South Florida Research Phase I-IV — Miami, Florida, United States (enrolling)
• Miami Jewish Health System — Miami, Florida, United States (enrolling)
• Sunshine Medical Research Studies Inc — Miami, Florida, United States (enrolling)
• Charter Research — Orlando, Florida, United States (enrolling)
• Homestead Associates in Research Inc — Homestead, Florida, United States (enrolling)
• Psych Me Medical Research Inc — Tampa, Florida, United States (enrolling)
• Quantum Research Associates Corp — Tampa, Florida, United States (enrolling)
• State Psychiatric Hospital - Lovech — Lovech, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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