Psychotic Disorders study: ITI-1284
Official title A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
ClinicalTrials.gov ID: NCT06540833
What this study is testing
What is ITI-1284?
ITI-1284 is an investigational once‑daily sublingual tablet being studied for the treatment of psychosis in patients with AD.
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 study is testing whether ITI‑1284 helps reduce psychosis in Alzheimer’s patients. It also looks at how safe it is.
- Who it's for
- You may be able to join if you have Alzheimer’s disease and experience psychosis symptoms.
- What's involved
- You will receive either ITI‑1284 or a pretend treatment. You will take the medicine at home and visit the clinic for check‑ins and tests.
- Time commitment
- The study lasts several months and requires regular clinic visits and follow‑up appointments.
- 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 AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately...
- Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and...
- Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B.
You likely can't join if
- Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia
- Bipolar disorder
- 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...
- The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or...
- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
- Place the patient at undue risk from study drug or undergoing study procedures; or
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 AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
- Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan
- Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline
- Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline
- CGI-S score ≥ 4 at Screening and Baseline
- Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures
- Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)
- Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia
- Bipolar disorder
- 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 C-SSRS
- The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the...
- The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
- Place the patient at undue risk from study drug or undergoing study procedures; or
- Interfere with the interpretation of safety or how well it works evaluations performed during the course of the study
- The patient is in hospice or end-of-life care
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Walnut Creek, California, United States
- Bonita Springs, Florida, United States
- Brandon, Florida, United States
- Doral, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Savannah, Georgia, United States
- Toms River, New Jersey, United States
- Charlotte, North Carolina, United States
- Matthews, North Carolina, United States
- Cypress, Texas, United States
- Bellevue, Washington, United States
- Cherven Bryag, Bulgaria
- Sofia, Bulgaria
- Stara Zagora, Bulgaria
- Zagreb, Croatia
+ 16 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; Bonita Springs, Florida, United States; Brandon, Florida, United States; Doral, Florida, United States; Homestead, Florida, United States and 30 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.