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Tests treatment safety and results for Psychosis Associated With Alzheimer's Disease
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 medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for psychosis associated with alzheimer's disease.
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, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.
- 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 AD based on 2011 NIA-AA criteria and either:
- Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; 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...
You likely can't join if
- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has...
- 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
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 AD based on 2011 NIA-AA criteria and either:
- Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; 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);
- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or 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;
- 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; or...
- 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
- The patient is bedridden or has any significant medical condition that is unstable and would either:
- 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's taking place
- Anaheim, California, United States
- Los Alamitos, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Walnut Creek, California, United States
- Bonita Springs, Florida, United States
- Brandon, Florida, United States
- Coral Springs, Florida, United States
- Delray Beach, Florida, United States
- Doral, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Toms River, New Jersey, United States
- Charlotte, North Carolina, United States
- Cypress, Texas, United States
- San Antonio, Texas, 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; Los Alamitos, California, United States; Newport Beach, California, United States; Orange, California, United States; Walnut Creek, California, 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.
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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.