Agitation Associated With Alzheimer's Dementia study: ITI-1284
Official title 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
What this study is testing
What is ITI-1284?
ITI-1284 is an investigational once‑daily sublingual tablet being studied for agitation associated with Alzheimer’s dementia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if ITI‑1284 helps reduce agitation and if it is safe for patients with Alzheimer’s dementia.
- Who it's for
- Adults who have Alzheimer’s dementia and experience agitation.
- What's involved
- Participants will receive either ITI‑1284 or a placebo in a double‑blind design, with doses adjusted as needed. They will attend clinic visits for monitoring and testing.
- Time commitment
- The study lasts several months, with multiple clinic visits for dosing, safety checks, and assessments.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is...
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an...
- Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
- Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
- Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening...
You likely can't join if
- Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric...
- Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
- Bipolar disorder;
- Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
- 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...
- The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.
See the full eligibility criteria
- Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent...
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
- Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
- Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
- CGI-S score ≥ 4 at Screening and Baseline;
- Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;
- Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
- Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
- Bipolar disorder;
- Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
- 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...
- The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Walnut Creek, California, United States
- Boca Raton, Florida, United States
- Bonita Springs, Florida, United States
- Brandon, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- Toms River, New Jersey, United States
- San Antonio, Texas, United States
- Lovech, Bulgaria
- Pleven, Bulgaria
- Sofia, Bulgaria
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Walnut Creek, California, United States; Boca Raton, Florida, United States; Bonita Springs, Florida, United States; Brandon, Florida, United States; Doral, Florida, United States and 36 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.