ITI-1284-201

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 psychosis in patients with Alzheimer’s disease.

How long will the treatment last?

• The treatment period is 6 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 psychotic symptoms (BEHAVE-AD 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)
• Have psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition and must have score above 2 on any item of the BEHAVE-AD test
• Have a score between 6 and 24 points in the MMSE test (a test about your general thinking skills)
• Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

• Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (e.g., hypothyroidism) or diagnosis of psychiatric conditions such as schizophrenia and bipolar disorder
• Risk for suicidal behavior
• Hospitalisation or receiving skilled nursing care for any medical condition other than dementia
• Hospice or end-of-life care.

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

NCT06540833

EU CT Number

2024-513035-25-00

Study contact information

ITCIClinicalTrials@itci-inc.comm/u>

Link to full text

https://clinicaltrials.gov/study/NCT06540833 

https://euclinicaltrials.eu/ctis-public/view/2024-513035-25-00 

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov, CTIS websites) in November 2025.

This document has been reviewed by a member of the European Dementia Carers Working Group.