Alzheimer Disease study: KarXT
Official title A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
ClinicalTrials.gov ID: NCT06585787
What this study is testing
What is KarXT?
KarXT is an investigational oral medication being studied for mild to severe Alzheimer’s disease with psychosis.
Also referred to as BMS-986510.
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 aims to see if KarXT is safe and works for people with Alzheimer’s who have moderate to severe psychosis.
- Who it's for
- Adults who have mild to severe Alzheimer’s disease and moderate to severe psychosis related to the disease.
- What's involved
- Participants will receive the drug KarXT and will have regular clinic visits and medical tests to monitor their condition.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
- Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during...
- Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to...
You likely can't join if
- i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective...
- ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder...
- iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
- \ Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Chino, California, United States
- Los Angeles, California, United States
- Farmington, Connecticut, United States
- Bonita Springs, Florida, United States
- Daytona Beach, Florida, United States
- Naples, Florida, United States
- Ocoee, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- The Villages, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Belmont, Massachusetts, United States
- Boston, Massachusetts, United States
- North Dartmouth, Massachusetts, United States
- Springfield, Massachusetts, United States
- Bloomfield Township, Michigan, United States
+ 113 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Phoenix, Arizona, United States; Anaheim, California, United States; Chino, California, United States; Los Angeles, California, United States; Farmington, Connecticut, United States and 127 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.