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A Phase 3, Parallel Group Study to Evaluate KarXT as a Treatment for Psychosis Associated with Alzheimer’s Disease
EU CTIS ID: 2024-516363-92-00
What this study is testing
The main objectives of the trial are to evaluate the efficacy of KarXT compared with placebo in the treatment of psychosis in participants with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C):Hallucinations and Delusions (H+D) score
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patients who are 55-90 years old
- • Diagnosed with AD based on the 2024 National Institute on Aging – Alzheimer’s Association criteria with AD biomarker confirmation
- • Participants who have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma
- • Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation)
You likely can't join if
- • Patients will not be able to participate if they have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
- • History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- • Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Argentina
- India
- Serbia
- Japan
- Turkey
- Israel
- Korea, Republic of
- Puerto Rico
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Argentina; India; Serbia; Japan and 4 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 EU CTIS; the study team decides eligibility.