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Study on ITI-1284 for Treating Agitation 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 a condition known as agitation associated with Alzheimer's disease. This condition often involves symptoms such as restlessness, irritability, and aggressive behavior in individuals with Alzheimer's. The study will test a new treatment called ITI-1284, which is a tablet taken by placing it under the tongue. The purpose of the study is to evaluate how effective and safe ITI-1284 is in reducing agitation symptoms compared to a placebo.

Participants in the study will receive either the ITI-1284 tablet or a placebo tablet. The study will last for about 12 weeks, during which participants will take the medication once daily. Throughout the study, participants will be monitored to see how their symptoms change over time. The main goal is to see if there is an improvement in the symptoms of agitation by the end of the study period.

This trial aims to provide valuable information on whether ITI-1284 can be a helpful treatment for managing agitation in people with Alzheimer's disease. By comparing the effects of ITI-1284 to a placebo, researchers hope to determine the potential benefits and safety of this new treatment option.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes a review of your medical history and a series of assessments to ensure you meet the study criteria.

    You will undergo a Mini Mental State Examination to assess your cognitive function. This is a simple test that evaluates your memory, attention, and language skills.

    Your caregiver or legally authorized representative will accompany you to this visit to provide additional information and support.

  2. Step 2

    Baseline assessment

    During the baseline assessment, your current symptoms of agitation will be evaluated using specific scales, such as the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory–Agitation/Aggression (NPI-AA) domain.

    This assessment helps to establish a starting point for measuring changes in your symptoms throughout the study.

  3. Step 3

    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 your tongue to dissolve.

    The dosage of ITI-1284 will be flexible, starting at 10 mg and potentially increasing to 20 mg, based on your response and tolerance. The medication is taken once daily for the duration of the study.

  4. Step 4

    Regular follow-up visits

    You will have regular follow-up visits at the clinic to monitor your progress and any side effects. These visits will occur at scheduled intervals throughout the 12-week study period.

    During these visits, your symptoms will be reassessed using the same scales as the baseline assessment to track any changes.

  5. Step 5

    Final assessment

    At the end of the 12-week study period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    This will include a comprehensive review of your symptoms, any side effects experienced, and your overall health status.

Who can join the trial?

11 criteria

  • The patient must be able to provide consent to participate in the study. If the patient cannot provide consent, a representative like a caregiver or family member can do so.
  • The patient should have a Mini Mental State Examination score between 6 and 24. This is a test that checks memory and thinking skills.
  • The patient must live at home or in a care facility and be able to visit the clinic. If living at home, the patient should not live alone and must have a caregiver accompany them to study visits.
  • The patient must be a male or female aged 55 years or older.
  • The patient should 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 have shown symptoms of agitation for at least 2 weeks before the study starts.
  • The patient must meet the clinical criteria for Alzheimer's disease based on specific tests or historical medical records.
  • The patient must show signs of agitation, such as excessive movement, verbal or physical aggression, and these behaviors should cause significant problems in daily life.
  • The patient must have a Neuropsychiatric Inventory score of 4 or higher, which measures agitation and aggression.
  • The patient must meet criteria for aggressive behavior, such as having one or more aggressive actions several times a week.
  • The patient must have a Clinical Global Impression-Severity score of 4 or higher, which assesses the severity of the condition.

Who cannot join the trial?

9 criteria

  • Patients who do not have Alzheimer's Dementia cannot participate.
  • Patients who are not experiencing agitation related to Alzheimer's Dementia cannot participate. Agitation means feeling restless or very upset.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This means if you have another illness that could affect the study results, you might not be eligible.
  • Patients who are taking medications that might interfere with the study cannot participate. This means if you are on certain drugs that could affect the study, you might not be eligible.
  • Patients who have participated in another clinical trial recently cannot participate. This is to ensure that previous treatments do not affect the study results.
  • Patients who have a history of substance abuse cannot participate. Substance abuse means using drugs or alcohol in a way that is harmful.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of the mother and child.
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Investigated drugs

ITI-1284 is a medication being studied for its potential to help reduce agitation in patients with Alzheimer's dementia. Agitation can include symptoms like restlessness, irritability, and aggression, which are common in people with Alzheimer's. This medication is taken once a day, and the study aims to see how well it works in calming these symptoms over a period of 12 weeks. The goal is to improve the quality of life for patients by making them feel more at ease and less agitated. The effectiveness of the medication is measured by observing changes in behavior from the start of the study to the end.

What is already known about the treatment

ITI-1284 – ITI-1284 is administered in a flexible-dose form, taken once daily, and is currently being studied in clinical trials for its effectiveness in treating agitation associated with Alzheimer's dementia. This medication is still under investigation, and its status in medical literature is primarily within the context of ongoing research. The main therapeutic indication for ITI-1284 is to help manage agitation symptoms in patients with Alzheimer's dementia. At the molecular level, ITI-1284 works by influencing certain brain chemicals that may be involved in mood and behavior regulation. It is classified pharmacologically as a treatment for neuropsychiatric symptoms related to dementia.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The disease is associated with the accumulation of amyloid plaques and tau tangles in the brain. It is the most common cause of dementia among older adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514680-26-00Protocol codeITI-1284-101Estimated enrolment320 patientsSponsorIntra-Cellular Therapies Inc.

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