ITI-1284 for Agitation in Dementia

Recruiting at 12 trial locations

Overseen By ITI Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ITI-1284 (also known as deuterated lumateperone), to determine if it reduces agitation in people with Alzheimer's dementia. Agitation often appears as restlessness or irritability and can significantly impact daily life. Participants will take either the experimental treatment or a placebo (a pill with no active drug) once a day under their tongue. Suitable candidates for this trial include those diagnosed with Alzheimer's dementia who experience significant agitation that disrupts daily activities. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your agitation symptoms are due to your current medications, you might not be eligible to participate.

Is there any evidence suggesting that ITI-1284 is likely to be safe for humans?

Research has shown that ITI-1284 is being tested for safety and effectiveness in treating agitation in people with Alzheimer's dementia. This treatment is currently in the middle phase of clinical trials, indicating it has already undergone some testing in humans. Although detailed safety information from earlier studies isn't available, ITI-1284's progression to this stage suggests it has demonstrated sufficient safety to continue testing in patients.

For those considering joining the trial, it's important to know that this medication is a tablet that dissolves quickly under the tongue and is taken once a day. This method may assist individuals who have difficulty swallowing. Always consult a healthcare provider for more personalized information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dementia?

Most treatments for agitation in dementia involve antipsychotics or sedatives, which can have significant side effects. Unlike these standard options, ITI-1284 is a rapidly disintegrating tablet taken sublingually, allowing for quicker absorption and potentially faster relief of symptoms. Researchers are excited about ITI-1284 because it offers a novel mechanism of action that targets specific pathways in the brain, potentially reducing agitation without the heavy sedation often seen in current treatments. Additionally, its unique delivery method could improve patient compliance and comfort.

What evidence suggests that ITI-1284 might be an effective treatment for agitation in dementia?

Studies have shown that ITI-1284 might help treat agitation in people with Alzheimer's dementia. ITI-1284 contains lumateperone, which affects brain chemicals related to mood and behavior, helping manage behavioral symptoms often seen in dementia. While research is ongoing, early results suggest it may effectively reduce agitation. The mechanism of ITI-1284 makes it a promising option for managing these difficult symptoms. Participants in this trial will receive either ITI-1284 or a placebo to further evaluate its effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's who experience agitation or psychosis. Participants should be in a stable condition and have a caregiver available. People with other types of dementia, unstable medical conditions, or those using certain medications that affect the brain may not qualify.

Inclusion Criteria

Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline

Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening

Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition

Exclusion Criteria

Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening

The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients

My agitation is not due to drugs, environment, substance abuse, or other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Double-blind Treatment

Participants are randomized to receive either ITI-1284 or placebo for 12 weeks

12 weeks

Safety Follow-up

Participants are monitored for safety approximately 30 days after the last dose of study drug

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ITI-1284

Trial Overview The study tests ITI-1284's effectiveness and safety against placebo in managing Alzheimer's-related agitation. Patients are randomly assigned to receive either ITI-1284 or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: ITI-1284 Experimental Treatment 1 Intervention

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

Group II: Placebo Placebo Group 1 Intervention

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Published Research Related to This Trial

Lumateperone (ITI-007) has a unique mechanism of action that targets multiple neurotransmitter systems, including serotonin, dopamine, and glutamate, making it a promising treatment for schizophrenia and potentially other psychiatric conditions.

It has shown a favorable safety profile, with no significant side effects like extrapyramidal symptoms or hyperprolactinemia, suggesting it could be a safer alternative to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence on the New Drug Lumateperone (ITI-007) for Psychiatric and Neurological Disorders. Mazza, M., Marano, G., Traversi, G., et al.[2021]

In a study involving 176 hospitalized dementia patients, both tiapride and melperone were found to be equally effective in reducing psychomotor agitation, with a response rate of 74.36% for both treatments.

The safety profile of tiapride was comparable to melperone, with no significant changes in vital signs or serious adverse events, indicating that tiapride is a safe alternative for managing agitation in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the efficacy of psychopharmacological treatment of psychomotoric restlessness in dementia: clinical evaluation of tiapride. Gutzmann, H., Kühl, KP., Kanowski, S., et al.[2013]

In a multicenter trial involving 153 nursing home residents with dementia, divalproex sodium (target dose of 750 mg/day) showed no significant benefit in reducing agitation compared to placebo over 6 weeks.

Safety and tolerability measures indicated no clinically important differences between divalproex and placebo, contradicting earlier studies that suggested potential benefits for treating agitation in dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divalproex sodium in nursing home residents with possible or probable Alzheimer Disease complicated by agitation: a randomized, controlled trial. Tariot, PN., Raman, R., Jakimovich, L., et al.[2017]

Lumateperone tosylate is a first-in-class investigational drug that works through multiple neurotransmitter systems, including serotonergic, dopaminergic, and glutamatergic pathways, which may lead to rapid antidepressant effects.

In clinical trials, lumateperone demonstrated a safety profile similar to placebo, with significant improvements in both depressive and psychotic symptoms in patients with schizophrenia, indicating its potential for treating various mood disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: a new treatment approach for neuropsychiatric disorders. Kumar, B., Kuhad, A., Kuhad, A.[2019]

Haloperidol showed no overall improvement in agitation among demented patients compared to placebo, although it may help control aggression in some cases.

Patients treated with haloperidol experienced more side effects and higher dropout rates, particularly with higher doses (over 2 mg per day) and prolonged therapy (more than 3-6 weeks), indicating safety concerns with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haloperidol for agitation in dementia. Lonergan, E., Luxenberg, J., Colford, J.[2018]

Current treatments for behavioral and psychological symptoms in dementia, such as cholinesterase inhibitors and antipsychotics, show limited effectiveness and can lead to serious side effects, highlighting the need for new options.

Novel agents like dextromethorphan/quinidine and lumateperone have shown promising results in clinical trials and are generally well tolerated, suggesting they could be effective alternatives for managing these symptoms in dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Agents in Development for Treating Behavioral and Psychological Symptoms Associated with Dementia. Ahmed, M., Malik, M., Teselink, J., et al.[2022]

In a study of 18 outpatients with dementia over 6 weeks, the serotonin dopamine antagonist perospirone (PER) significantly improved aggressive and agitated behaviors, particularly reducing verbal outbursts and agitation scores.

The study found PER to be safe for elderly patients, with only 2 participants dropping out due to mild adverse effects and no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of perospirone in the management of aggressive behavior associated with dementia. Sato, S., Mizukami, K., Moro, K., et al.[2012]

In a 6-week study involving 6 patients with dementia, perospirone effectively reduced aggressive and agitated behaviors, with significant improvements observed within just 2 weeks.

The maximum benefit was noted at a mean dose of 9.0 mg/day, and importantly, no severe adverse effects were reported, indicating that perospirone is a safe treatment option for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of perospirone on aggressive behavior associated with dementia. Sato, S., Mizukami, K., Moro, K., et al.[2012]

In a study involving 313 individuals with moderate Alzheimer's disease, treatment with divalproex sodium (valproate) did not delay or prevent the emergence of agitation or psychosis compared to a placebo, indicating it may not be an effective intervention for these symptoms.

The valproate group experienced significant side effects, including increased somnolence, gait disturbances, and greater brain volume loss, suggesting that the risks of using valproate may outweigh any potential benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic divalproex sodium to attenuate agitation and clinical progression of Alzheimer disease. Tariot, PN., Schneider, LS., Cummings, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06651567

A Study to Assess the Efficacy and Safety of ITI-1284 in ... A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia. ClinicalTrials.gov ID NCT06651567.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/547760

A Study to Assess the Efficacy and Safety of ITI-1284 in ... This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ...

3. withpower.com withpower.com/trial/phase-2-dementia-9-2024-a7b6c

ITI-1284 for Agitation in Dementia Lumateperone, a component of ITI-1284, has shown potential in treating behavioral symptoms of dementia and Alzheimer's disease due to its unique action on brain ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06651567/a-study-to-assess-the-efficacy-and-safety-of-iti-1284-in-the-treatment-of-agitation-associated-with-alzheimers-dementia

A Study to Assess the Efficacy and Safety of ITI-1284 in ... This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7048860/

Management of Dementia-Related Psychosis, Agitation and ... A randomized, double-blind, pilot study evaluated the effectiveness of escitalopram (5–10 mg/day) in reducing psychotic symptoms and agitation in 40 patients ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=3d84e631-13ef-4920-bf87-654358a4c962

lumateperone deuterated (ITI-1284 ODT-SL) / J&J We plan to initiate our program for the development of ITI-1284-ODT-SL for the treatment of behavioral disturbances in dementia in the second half of 2021.