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Tests treatment safety and results for Alzheimer Disease
Official title A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
ClinicalTrials.gov ID: NCT06947941
What this study is testing
What is KarXT?
KarXT is an investigational medicine, being studied as a potential treatment for alzheimer disease.
Also referred to as BMS-986510, Xanomeline/Trospium Chloride.
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 purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
- 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
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's...
- Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken...
- Participants 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
- Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg...
- Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar...
- Participants must not 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's taking place
- Gilbert, Arizona, United States
- Chino, California, United States
- Naples, Florida, United States
- Cleveland, Ohio, United States
- Independence, Ohio, United States
- Macquarie Park, New South Wales, Australia
- Nedlands, Western Australia, Australia
- Toronto, Ontario, Canada
- Whitby, Ontario, Canada
- Montreal, Quebec, Canada
- Suita, Osaka, Japan
- Nankoku-shi, Japan
- Osaka, Japan
- Exeter, Devon, United Kingdom
- London, England, United Kingdom
- Oxford, Oxfordshire, United Kingdom
- Chertsey, Surrey, United Kingdom
- Sheffield, Yorkshire and the Humber, United Kingdom
- Crowborough, United Kingdom
- London, United Kingdom
+ 1 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Chino, California, United States; Naples, Florida, United States; Cleveland, Ohio, United States; Independence, Ohio, United States; Macquarie Park, New South Wales, Australia and 15 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.