A study to assess the efficacy and safety of ITI-1284 in the treatment of agitation associated with Alzheimer's dementia
Information about the drug that will be tested in the study
Administration
Oral tablet once daily (sublingual administration)
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- An oral tablet of ITI-1284 (10mg)
- An oral tablet of ITI-1284 (20mg)
- An oral tablet of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The study will evaluate the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of agitation associated with Alzheimer’s dementia.
How long will the treatment last?
- The treatment period is 12 weeks.
- The treatment period will be followed by a safety follow-up period of 30 days which all participants will return for a safety follow-up visit approximately 30 days after the last dose of study drug
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their behaviour (CMAI test) and overall mental health (CGI-S test).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 55 years old or older
- Be able to provide consent before the initiation of any study-specific procedures
- Have a body mass index (BMI) of 18–40 kg/m2 inclusive
- Have a diagnosis of Alzheimer’s disease according to the 2011 NIA-AA criteria
- Have evidence of abnormal accumulation of amyloid in the brain (determined either through CSF examination (lumbar puncture) or with the use of an amyloid PET scan or confirmed by blood-based biomarker)
- Meet 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
- Have a score between 6 and 24 points in the MMSE test (a test about your general thinking skills).
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Agitation symptoms attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions
- Diagnosis of psychiatric conditions such as schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia; bipolar disorder or major depressive disorder
- Risk for suicidal behaviour.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT06651567
EU CT Number
2024-514680-26-00
Study contact information
ITCIClinicalTrials@itci-inc.com/u>
Link to full text
https://clinicaltrials.gov/study/NCT06651567
https://euclinicaltrials.eu/ctis-public/view/2024-514680-26-00
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov, CTIS websites) in September 2025.
This document has been reviewed by a member of the European Dementia Carers Working Group.
