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Iti-1284

ITI-1284 is an investigational drug being studied in various clinical trials for its potential in treating conditions such as agitation and psychosis associated with Alzheimer’s dementia, as well as generalized anxiety disorder. These trials aim to assess the drug’s efficacy, safety, and tolerability in different patient populations. Additionally, studies are being conducted to understand the drug’s pharmacokinetics and its interaction with brain receptors in healthy volunteers.

Table of Contents

What is ITI-1284?

ITI-1284 is a new medication currently being studied for its potential to treat various mental health conditions. It is undergoing clinical trials to evaluate its effectiveness, safety, and how well patients tolerate it. The drug is being tested in different dosages, typically 10 mg and 20 mg[1][2].

How is ITI-1284 Administered?

ITI-1284 is administered as a sublingual tablet. This means the tablet is placed under the tongue, where it quickly dissolves. It is typically taken once daily[3][4]. Some studies describe ITI-1284 as a rapidly disintegrating tablet, which suggests it dissolves quickly in the mouth[5].

Conditions Treated by ITI-1284

ITI-1284 is being studied for several mental health conditions:

  • Generalized Anxiety Disorder (GAD): This is a condition characterized by persistent and excessive worry about various aspects of life[2][3].
  • Agitation Associated with Alzheimer’s Dementia: This refers to restlessness, emotional distress, or aggressive behavior that can occur in people with Alzheimer’s disease[4].
  • Psychosis Associated with Alzheimer’s Disease: This involves experiencing hallucinations (seeing or hearing things that aren’t there) or delusions (false beliefs) in people with Alzheimer’s disease[5].

Ongoing Clinical Trials

Several clinical trials are currently underway to study ITI-1284:

  1. PET Study in Healthy Volunteers: This study aims to understand how ITI-1284 interacts with dopamine D2 receptors in the brain. It also looks at the drug’s safety and how it moves through the body (pharmacokinetics)[1].
  2. Generalized Anxiety Disorder (GAD) Studies: Two separate studies are examining ITI-1284 for GAD:
    • One study is testing ITI-1284 as a standalone treatment (monotherapy) for GAD[2].
    • Another study is evaluating ITI-1284 as an additional treatment (adjunctive therapy) for patients who haven’t responded well to other GAD treatments[3].
  3. Alzheimer’s Disease Studies: Two studies are focusing on symptoms associated with Alzheimer’s disease:
    • One study is investigating ITI-1284 for treating agitation in Alzheimer’s patients[4].
    • Another study is examining ITI-1284’s effectiveness in treating psychosis in Alzheimer’s patients[5].

Safety and Side Effects

While the full safety profile of ITI-1284 is still being studied, the clinical trials are monitoring several aspects of safety:

  • Treatment-emergent adverse events: These are any unfavorable and unintended signs, symptoms, or diseases that occur during the treatment period[1].
  • Changes in ECG QT interval: This is a measure of the heart’s electrical activity and can indicate potential heart-related side effects[1].
  • Changes in liver enzymes: Specifically, aspartate aminotransferase and alanine aminotransferase are being monitored, which can indicate potential effects on liver function[1].

It’s important to note that all medications can have side effects, and the full range of potential side effects for ITI-1284 will become clearer as more research is conducted.

Measuring Effectiveness

The clinical trials are using several standardized scales to measure how well ITI-1284 works:

  • Hamilton Anxiety Rating Scale (HAM-A): This scale measures both psychological and physical symptoms of anxiety. It includes 14 items rated from 0 (not present) to 4 (very severe). A higher score indicates more severe anxiety[2][3].
  • Clinical Global Impression Scale-Severity (CGI-S): This scale assesses a patient’s overall mental health. It ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)[2][3][4][5].
  • Cohen-Mansfield Agitation Inventory (CMAI): This scale is used to assess agitated behavior in elderly patients. It includes 29 items, each rated on a 7-point scale of frequency[4].
  • BEHAVE-AD psychosis subscale: This scale is used to measure psychotic symptoms in Alzheimer’s disease patients. It includes items related to paranoid and delusional ideations, as well as hallucinations[5].

These scales help researchers determine if ITI-1284 is effectively reducing symptoms of the conditions it’s being tested to treat.

Aspect Details
Drug Name ITI-1284
Conditions Studied Agitation in Alzheimer’s Dementia, Psychosis in Alzheimer’s Disease, Generalized Anxiety Disorder
Administration Sublingual, once daily
Doses Tested 10 mg and 20 mg
Study Designs Randomized, double-blind, placebo-controlled
Treatment Duration 6-12 weeks
Primary Outcome Measures CMAI, BEHAVE-AD psychosis subscale, HAM-A
Secondary Outcome Measures CGI-S, adverse events, vital signs, laboratory tests
Additional Studies Mass balance, brain receptor occupancy, pharmacokinetics in healthy volunteers

FAQ

  • What conditions is ITI-1284 being studied for? ITI-1284 is being studied for agitation and psychosis associated with Alzheimer's dementia, as well as generalized anxiety disorder (GAD).
  • How is ITI-1284 administered in these trials? In most trials, ITI-1284 is administered as a rapidly disintegrating tablet taken once daily via sublingual (under the tongue) administration.
  • What are the typical doses of ITI-1284 being tested? The trials are testing doses of 10 mg and 20 mg of ITI-1284.
  • How long do the treatment periods in these trials typically last? Treatment periods vary, but they generally range from 6 to 12 weeks, followed by a safety follow-up period.
  • What types of measurements are being used to assess the effectiveness of ITI-1284? Various scales are being used, including the Cohen-Mansfield Agitation Inventory (CMAI) for agitation, the BEHAVE-AD psychosis subscale for psychosis, and the Hamilton Anxiety Rating Scale (HAM-A) for anxiety. Additionally, the Clinical Global Impression-Severity (CGI-S) scale is commonly used across studies to assess overall mental health.

Ongoing Clinical Trials on Iti-1284

  • Study on ITI-1284 for Patients with Generalized Anxiety Disorder Who Did Not Respond Well to Previous Treatments

    Recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia Finland Poland Slovakia

  • Study on ITI-1284 for Treating Agitation in Alzheimer’s Patients

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Romania Slovakia Spain

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

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Italy Poland Romania +2

  • Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment

    Recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia Finland Poland

Glossary

  • Alzheimer's Dementia: A progressive brain disorder that affects memory, thinking, and behavior, typically in older adults.
  • Agitation: A state of anxiety or nervous excitement, often accompanied by restlessness and tension.
  • Psychosis: A mental state characterized by a disconnection from reality, which may involve hallucinations or delusions.
  • Generalized Anxiety Disorder (GAD): A mental health condition characterized by persistent and excessive worry about various aspects of life.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Sublingual Administration: A method of giving medication by placing it under the tongue to dissolve and be absorbed into the bloodstream.
  • Double-blind Study: A research design where neither the participants nor the researchers know who is receiving the actual treatment or a placebo.
  • Placebo: An inactive substance or treatment that looks like the real medication but has no therapeutic effect.
  • Cohen-Mansfield Agitation Inventory (CMAI): A tool used to assess agitated behavior in elderly patients, consisting of 29 items rated on a frequency scale.
  • Clinical Global Impression-Severity (CGI-S): A scale used by clinicians to rate the severity of a patient's mental illness, ranging from 1 (normal) to 7 (extremely ill).
  • Hamilton Anxiety Rating Scale (HAM-A): A clinical scale used to measure the severity of anxiety symptoms, consisting of 14 items rated on a 5-point scale.
  • Positron Emission Tomography (PET): An imaging technique that uses radioactive tracers to visualize and measure metabolic processes in the body.
  • Receptor Occupancy: The degree to which drug molecules bind to and occupy specific receptors in the body, influencing the drug's effects.

References