Alzheimer's Disease study: Xanomeline Enteric Capsule
Official title A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
ClinicalTrials.gov ID: NCT07011745
What this study is testing
What is Xanomeline/Trospium Chloride Capsule?
An investigational oral capsule being studied for agitation in Alzheimer’s disease.
Also referred to as KarXT, 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
- This study is testing whether KarXT + KarX-EC can reduce agitation in people with Alzheimer’s disease and how safe it is.
- Who it's for
- You may be able to join if you are an adult with Alzheimer’s disease and have agitation symptoms.
- What's involved
- You will take the study medication at home and have visits to check your symptoms and health. The team will monitor you for side effects.
- Time commitment
- The study lasts about 12 weeks, with several clinic visits during that time.
- 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
- Amyloid PET.
- Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
- Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
- Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to: i) Attend all visits and report on...
- History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with...
You likely can't join if
- \- Medical Conditions.
- i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- \- Prior/Concomitant Therapy.
See the full eligibility criteria
- Amyloid PET.
- Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
- Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
- Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to: i) Attend all visits and report on participant's status.
- History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
- AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
- Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and Visit 2.
- \- Medical Conditions.
- i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- \- Prior/Concomitant Therapy.
- i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other...
- A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
- B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
- Note: Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- \- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Garden Grove, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Aventura, Florida, United States
- Bonita Springs, Florida, United States
- Bradenton, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Hattiesburg, Mississippi, United States
- Las Vegas, Nevada, United States
- Toms River, New Jersey, United States
- Staten Island, New York, United States
- Valley Stream, New York, United States
- Morehead City, North Carolina, United States
- Blue Ash, Ohio, United States
- Carrollton, Texas, United States
- Cypress, Texas, United States
- Mesquite, Texas, United States
+ 66 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 Chandler, Arizona, United States; Garden Grove, California, United States; Long Beach, California, United States; Orange, California, United States; Aventura, Florida, United States; Bonita Springs, Florida, United States and 80 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.