A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Recruiting · NCT06540833 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ITI-1284Placebo
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 AD based on 2011 NIA-AA criteria and either:
- Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
- 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
- CGI-S score ≥ 4 at Screening and Baseline
- 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
- Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)
Exclusion criteria
- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (for example, hypothyroidism) or 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
- 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
- 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
- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
- The patient is bedridden or has any significant medical condition that is unstable and would either:
- Place the patient at undue risk from study drug or undergoing study procedures; or
- Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study
- The patient is in hospice or end-of-life care
Where it is running
60 locations listed across 7 US states.
- Advanced Research Center, Inc - Anaheim, California, United States
- Pharmacology Research Institute - Los Alamitos, California, United States
- Wr Pri Llc - Newport Beach, California, United States
- ATP Clinical Research - Orange, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Envision Trials LLC - Bonita Springs, Florida, United States
- Clinical Research of Brandon - Brandon, Florida, United States
- Healthcare Innovations Institute Inc - Coral Springs, Florida, United States
- Brain Matters Research - Delray Beach, Florida, United States
- Science Connections LLC - Doral, Florida, United States
- Homestead Associates in Research Inc - Homestead, Florida, United States
- K2 Medical Research - Maitland, Florida, United States
- Wellness Research Center - Miami, Florida, United States
- Ocean Blue Medical Research Center Inc. - Miami, Florida, United States
- Allied Biomedical Research Institute (ABRI), Inc - Miami, Florida, United States
- South Florida Research Phase I-IV - Miami, Florida, United States
- Sunshine Medical Solution - Miami, Florida, United States
- Combined Research Orlando - Orlando, Florida, United States
- Intercoastal Medical Group - Sarasota, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Psych Me Medical Research Inc - Tampa, Florida, United States
- CenExeli Research LLC - Savannah, Georgia, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- New Hope Clinical Research - Charlotte, North Carolina, United States
- Horizon Clinical Research Group - Cypress, Texas, United States
- University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Hosp. Gral. de Albacete - Albacete, Spain
- Neurologicka ambulancia MUDr.Dupejova s.r.o. - Banská Bystrica, Slovakia
- Clinical Center Dr Dragisa Misovic Dedinje - Belgrade, Serbia
- Medical Center Sv Dimitar Blagoevgrad - Blagoevgrad, Bulgaria
- Univerzitna nemocnica Bratislava - Bratislava, Slovakia
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili - Brescia, Italy
- Fakultni nemocnice u sv. Anny v Brne - Brno, Czechia
- Neuro Health Centrum s r o - Brno, Czechia
- Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' - Bucharest, Romania
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1 - Bucharest, Romania
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia - Bucharest, Romania
- Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian - Bucharest, Romania
- Przychodnia Srodmiescie SP. z o.o. - Bydgoszcz, Poland
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET - Cherven Bryag, Bulgaria
- Spitalul De Psihiatrie Elisabeta Doamna Galaţi - Galati, Romania
- NEUROHK s r o - Hradec Králové, Czechia
- Neuro Care - Katowice, Poland
- Special Hospital for Psychiatric Diseases Kovin - Kovin, Serbia
- Univerzitna nemocnica L. Pasteura Kosice - Košice, Slovakia
- Epamed sro - Košice, Slovakia
- University Clinical Center Kragujevac - Kragujevac, Serbia
- NEURES s r o - Krompachy, Slovakia
- University Clinical Center NIS - Niš, Serbia
- Special Hospital for Psychiatric Diseases Sveti Vracevi - Novi Kneževac, Serbia
- INEP medical s.r.o. - Prague, Czechia
- SC Carpe Diem SRL - Sibiu, Romania
- Mental Health Centre Prof. N Shipkovenski EOOD - Sofia, Bulgaria
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD - Sofia, Bulgaria
- Medical Center Hera EOOD - Sofia, Bulgaria
- Medical Center Intermedica, OOD - Sofia, Bulgaria
- UMHAT Prof. Dr. St. Kirkovich AD - Stara Zagora, Bulgaria
- Crystal Comfort s.r.o. - Vranov nad Topľou, Slovakia
- Mental Health Center - Vratsa EOOD - Vratsa, Bulgaria
Showing 60 of 67 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →