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Study on ITI-1284 for Treating Psychosis in Alzheimer's Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of psychosis associated with Alzheimer's disease. The treatment being tested is a medication called ITI-1284, which is administered in tablet form. The study aims to evaluate how effective and safe this medication is for patients experiencing psychosis, which is a condition that can cause people to see or hear things that are not there or hold false beliefs.

The trial involves comparing the effects of ITI-1284 with a placebo, which looks like the real medication but does not contain the active ingredient. Participants in the study will take the medication once daily for a period of six weeks. During this time, researchers will monitor changes in the participants' symptoms to determine how well the medication works in reducing the symptoms of psychosis.

The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The goal is to provide a clearer understanding of the potential benefits and safety of ITI-1284 for individuals with psychosis related to Alzheimer's disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide consent. If you are able to understand the nature of the trial, you will sign the consent form. If not, a representative, such as a caregiver or family member, will provide consent on your behalf.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to confirm eligibility. This includes checking your age, body mass index (BMI), and medical history related to Alzheimer's disease and psychosis.

    A series of tests will be conducted to confirm the presence of Alzheimer's disease and associated psychosis. This may involve blood tests or reviewing past medical records.

  3. Step 3

    Baseline evaluation

    A baseline evaluation will be conducted to assess your current condition. This includes scoring on the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) and the Clinical Global Impression-Severity (CGI-S) scale.

    Your ability to perform daily activities and your mental state will be evaluated using the Mini-Mental State Examination (MMSE-2).

  4. Step 4

    Medication administration

    You will be randomly assigned to receive either the study medication ITI-1284 or a placebo. The medication is administered as a sublingual tablet, which means it is placed under the tongue to dissolve.

    The dosage will be flexible, and you will take the medication once daily for a duration of six weeks.

  5. Step 5

    Weekly assessments

    Throughout the six-week period, you will have weekly assessments to monitor your response to the medication. This includes evaluating changes in your psychosis symptoms using the BEHAVE-AD scale.

    Your overall condition will also be assessed using the CGI-S scale to track any improvements or changes.

  6. Step 6

    End of study evaluation

    At the end of the six-week period, a final evaluation will be conducted. This will involve a comprehensive assessment of your condition and any changes in symptoms.

    The results from the BEHAVE-AD and CGI-S scales will be compared to the baseline to determine the efficacy of the treatment.

Who can join the trial?

10 criteria

  • The patient must be able to give consent to participate in the study. If the patient cannot give consent, a representative like a caregiver or family member can do it for them.
  • The patient must be a male or female who is at least 55 years old.
  • The patient must have a body mass index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
  • The patient must meet the clinical criteria for Alzheimer's Disease (AD), confirmed by specific tests or historical medical records.
  • The patient must have symptoms of psychosis related to Alzheimer's Disease. Psychosis includes symptoms like seeing or hearing things that are not there (hallucinations) or having false beliefs (delusions).
  • The patient must have had psychosis symptoms for at least one month, and these symptoms must be severe enough to affect daily activities.
  • The patient must score at least 2 on certain items of a test called the BEHAVE-AD, which measures psychosis symptoms.
  • The patient must have a score of 4 or higher on the Clinical Global Impression-Severity (CGI-S) scale, which measures the severity of the condition.
  • The patient must score between 6 and 24 on the Mini-Mental State Examination (MMSE-2), which tests mental abilities, and must be able to understand and answer questions.
  • The patient must live at home or in an assisted living or long-term care facility and be able to visit the clinic. If living at home, the patient must not live alone and must have been at their current location for at least 4 weeks before the study starts.

Who cannot join the trial?

5 criteria

  • Patients with any other type of psychosis not related to Alzheimer's Disease cannot participate. Psychosis means having trouble telling what is real and what is not, which can include seeing or hearing things that others do not.
  • Patients who are not within the specified age range for the study cannot participate. The study is for adults only.
  • Patients who are not able to give their own consent to participate in the study cannot join. Consent means agreeing to take part in the study after understanding what it involves.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate. This means if you have another illness that could affect the study results, you may not be able to join.
  • Patients who are currently participating in another clinical trial cannot join this study. This is to ensure that the results are not affected by other treatments.
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Investigated drugs

ITI-1284 is a medication being studied for its potential to help people with Alzheimer's disease who experience psychosis. Psychosis can include symptoms like seeing or hearing things that aren't there or having beliefs that are not based in reality. This medication is taken once a day and is being tested to see if it can reduce these symptoms and improve the quality of life for patients. The study aims to find out if ITI-1284 is effective and safe for use in people with Alzheimer's disease.

What is already known about the treatment

ITI-1284 – ITI-1284 is a medication currently being studied for its potential to treat psychosis associated with Alzheimer's disease. It is administered in a flexible-dose form, taken once daily. The main goal of the ongoing clinical trial is to assess its effectiveness, safety, and tolerability compared to a placebo. ITI-1284 works by targeting specific pathways in the brain that are believed to be involved in the symptoms of psychosis. It is classified under pharmacological agents that address psychiatric conditions, particularly those related to neurodegenerative diseases.

Investigated diseases

Psychosis associated with Alzheimer’s Disease – This condition involves the presence of psychotic symptoms in individuals diagnosed with Alzheimer’s Disease. It is characterized by delusions and hallucinations, which are false beliefs and sensory experiences that seem real but are not. These symptoms can lead to significant distress and may affect the individual's behavior and interactions with others. The progression of psychosis in Alzheimer’s Disease can vary, with symptoms potentially becoming more frequent or severe over time. The condition is often linked to changes in the brain associated with Alzheimer’s, which affect memory, thinking, and behavior. As the disease progresses, these psychotic symptoms may become more pronounced, impacting the quality of life for both the individual and their caregivers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513035-25-00Protocol code​ITI-1284-201Estimated enrolment388 patientsSponsorIntra-Cellular Therapies Inc.

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