A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
NCT ID: NCT06540833
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
370 participants
INTERVENTIONAL
2024-08-15
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia
NCT01900522
A Trial to Assess the Antipsychotic Efficacy of ITI-007
NCT02282761
Treatment of Psychosis and Agitation in Alzheimer's Disease
NCT02129348
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
NCT05545111
Safety and Tolerability of BI 409306 in Patients With Schizophrenia
NCT01892384
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
* Double-blind Treatment Period (6 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ITI-1284
ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ITI-1284
ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
Placebo
Placebo rapidly disintegrating tablet, taken once daily, sublingual administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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; 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. 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;
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Site
Anaheim, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Lafayette, California, United States
Clinical Site
Los Alamitos, California, United States
Clinical Site
Newport Beach, California, United States
Clinical Site
Orange, California, United States
Clinical Site
Bonita Springs, Florida, United States
Clinical Site
Brandon, Florida, United States
Clinical Site
Coral Springs, Florida, United States
Clinical Site
Delray Beach, Florida, United States
Clinical Site
Doral, Florida, United States
Clinical Site
Homestead, Florida, United States
Clinical Site
Maitland, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Sarasota, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Toms River, New Jersey, United States
Clinical Site
Charlotte, North Carolina, United States
Clinical Site
Cypress, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Blagoevgrad, , Bulgaria
Clinical Site
Cherven Bryag, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Stara Zagora, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
Clinical Site_2
Zagreb, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Brno, , Czechia
Clinical Site
Brno, , Czechia
Clinical Site
Hradec Králové, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Bydgoszcz, , Poland
Clinical Site
Ścinawa, , Poland
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Bucharest, , Romania
Clinical Site
Galati, , Romania
Clinical Site
Sibiu, , Romania
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Niš, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Clinical Site
Banská Bystrica, , Slovakia
Clinical Site
Bratislava, , Slovakia
Clinical Site
Košice, , Slovakia
Clinical Site
Košice, , Slovakia
Clinical Site
Krompachy, , Slovakia
Clinical Site
Vranov nad Topľou, , Slovakia
Clinical Site
Albacete, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Zamora, , Spain
Clinical Site
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITI-1284-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.