Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06651567 | RECRUITING | Agitation Associated With Alzheimer's Dementia

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

Intra-Cellular Therapies, Inc.

Brief Summary:

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

Condition or disease

Agitation Associated With Alzheimer's Dementia

Intervention/treatment

ITI-1284

Placebo

Phase

PHASE2

Detailed Description:

The study will be conducted in 3 periods: * Screening Period (up to 4 weeks) during which patient eligibility will be assessed; * Double-blind Treatment Period (12 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo; * Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.

Study Type : INTERVENTIONAL
Estimated Enrollment : 320 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-10-22
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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; 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.
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Location Details

NCT06651567

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

Clinical Site

Anaheim, California, United States, 92805

RECRUITING

United States, California

Clinical Site

Costa Table, California, United States, 92626

NOT YET RECRUITING

United States, California

Clinical Site

Newport Beach, California, United States, 92660

NOT YET RECRUITING

United States, Florida

Clinical Site

Boca Raton, Florida, United States, 33487

NOT YET RECRUITING

United States, Florida

Clinical Site

Bonita Springs, Florida, United States, 34134

NOT YET RECRUITING

United States, Florida

Clinical Site

Delray Beach, Florida, United States, 33445

NOT YET RECRUITING

United States, Florida

Clinical Site

Doral, Florida, United States, 33178

NOT YET RECRUITING

United States, Florida

Clinical Site

Maitland, Florida, United States, 32751

NOT YET RECRUITING

United States, Florida

Clinical Site

Miami, Florida, United States, 33032

NOT YET RECRUITING

United States, Florida

Clinical Site

Miami, Florida, United States, 33135

NOT YET RECRUITING

United States, Florida

Clinical Site

Miami, Florida, United States, 33137

RECRUITING

United States, Florida

Clinical Site

Miami, Florida, United States, 33155

RECRUITING

United States, Florida

Clinical Site

Miami, Florida, United States, 33186

NOT YET RECRUITING

United States, Florida

Clinical Site

Orlando, Florida, United States, 32803

NOT YET RECRUITING

United States, New Jersey

Clinical Site

Toms River, New Jersey, United States, 08755

NOT YET RECRUITING

United States, North Carolina

Clinical Site

Raleigh, North Carolina, United States, 27607

NOT YET RECRUITING

United States, Texas

Clinical Site

Round Rock, Texas, United States, 78681