RECRUITING

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

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Conditions

Psychosis Associated With Alzheimer's Disease

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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, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

Quick Facts

Study Start:2024-08-15
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06540833

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 CriteriaExclusion Criteria
  1. 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. 2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:
  3. 1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
  4. 2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
  5. 3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
  6. 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;
  7. 5. CGI-S score ≥ 4 at Screening and Baseline;
  8. 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;
  9. 7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);
  1. 1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:
  2. 1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
  3. 2. Bipolar disorder;
  4. 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;
  5. 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,
  6. 4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
  7. 5. The patient is bedridden or has any significant medical condition that is unstable and would either:
  8. 1. Place the patient at undue risk from study drug or undergoing study procedures; or
  9. 2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
  10. 6. The patient is in hospice or end-of-life care;

Contacts and Locations

Study Contact

ITI Clinical Trials
CONTACT
6464409333
ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site
Anaheim, California, 92805
United States
Clinical Site
Costa Mesa, California, 92626
United States
Clinical Site
Los Alamitos, California, 90720
United States
Clinical Site
Newport Beach, California, 92660
United States
Clinical Site
Coral Springs, Florida, 33067
United States
Clinical Site
Hialeah, Florida, 33012
United States
Clinical Site
Maitland, Florida, 32751
United States
Clinical Site
Miami Springs, Florida, 33166
United States
Clinical Site
Miami, Florida, 33032
United States
Clinical Site
Miami, Florida, 33155
United States
Clinical Site
Miami, Florida, 33156
United States
Clinical Site
Sarasota, Florida, 34239
United States
Clinical Site
Toms River, New Jersey, 08755
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 Date2024-08-15
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Psychosis Associated With Alzheimer's Disease