RECRUITING

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

Conditions

Agitation Associated With Alzheimer's Dementia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06651567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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; 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;	* 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.

Inclusion Criteria

Exclusion 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; 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;

* 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.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

646-440-9333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site

Anaheim, California, 92805

United States

Clinical Site

Costa Mesa, California, 92626

United States

Clinical Site

Newport Beach, California, 92660

United States

Clinical Site

Boca Raton, Florida, 33487

United States

Clinical Site

Bonita Springs, Florida, 34134

United States

Clinical Site

Delray Beach, Florida, 33445

United States

Clinical Site

Doral, Florida, 33178

United States

Clinical Site

Maitland, Florida, 32751

United States

Clinical Site

Miami, Florida, 33032

United States

Clinical Site

Miami, Florida, 33135

United States

Clinical Site

Miami, Florida, 33137

United States

Clinical Site

Miami, Florida, 33155

United States

Clinical Site

Miami, Florida, 33186

United States

Clinical Site

Orlando, Florida, 32803

United States

Clinical Site

Toms River, New Jersey, 08755

United States

Clinical Site

Raleigh, North Carolina, 27607

United States

Clinical Site

Round Rock, Texas, 78681

United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-10

Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

Agitation Associated With Alzheimer's Dementia