BridgeMD
Tests treatment safety and results for Alzheimer Disease
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 (ADAGIO-1)
ClinicalTrials.gov ID: NCT07011732
What this study is testing
What is Xanomeline/Trospium Chloride Capsule?
Xanomeline/Trospium Chloride Capsule is an investigational medicine, being studied as a potential treatment for alzheimer 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
- The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to 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
- \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD...
- 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...
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...
- 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...
- A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to...
- B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
See the full eligibility criteria
- \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid...
- 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. ii) Oversee participant compliance with medication...
- 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).
- CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (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...
- 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).
- C. 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's taking place
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- La Jolla, California, United States
- Pomona, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Maitland, Florida, United States
- Merritt Island, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Marrero, Louisiana, United States
- Gaithersburg, Maryland, United States
- Foxborough, Massachusetts, United States
- Newton, Massachusetts, United States
- South Dartmouth, Massachusetts, United States
- Springfield, Massachusetts, United States
- Bloomfield Hills, Michigan, United States
+ 111 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 Scottsdale, Arizona, United States; Anaheim, California, United States; La Jolla, California, United States; Pomona, California, United States; Torrance, California, United States; Walnut Creek, California, United States and 125 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.