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Tests treatment safety and results for Agitation Associated With Alzheimer's Dementia
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 medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment 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
- This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia
- 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...
- Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and...
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; 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
You likely can't join if
- Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric...
- Has been diagnosed with one or more of the following psychiatric conditions:
- 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...
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...
- Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:
- Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; 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;
- Has been diagnosed with one or more of the following psychiatric conditions:
- 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's taking place
- Anaheim, California, United States
- Costa Mesa, California, United States
- Garden Grove, California, United States
- Newport Beach, California, United States
- Boca Raton, Florida, United States
- Bonita Springs, Florida, United States
- Brandon, Florida, United States
- Delray Beach, 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
- Raleigh, North Carolina, United States
+ 29 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 - 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?
Study sites include Anaheim, California, United States; Costa Mesa, California, United States; Garden Grove, California, United States; Newport Beach, California, United States; Boca Raton, Florida, United States; Bonita Springs, Florida, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.