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)
Recruiting · NCT07011732 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboXanomeline Enteric CapsuleXanomeline/Trospium Chloride Capsule
What this trial is about
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.
Who can take part
Age range
55 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
- ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
- B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
- 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 and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
- 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).
Exclusion criteria
- \- 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 psychoactive medications except for as needed anxiolytics (eg, lorazepam).
- 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.
Where it is running
60 locations listed across 17 US states.
- Imaging Endpoints - Scottsdale, Arizona, United States
- Advanced Research Center (ARC) - Anaheim - Anaheim, California, United States
- Local Institution - 1637 - La Jolla, California, United States
- The Neurology Group - Pomona, California, United States
- Local Institution - 1639 - Torrance, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Local Institution - 1630 - Colorado Springs, Colorado, United States
- Local Institution - 1622 - Maitland, Florida, United States
- Local Institution - 1631 - Maitland, Florida, United States
- Local Institution - 1666 - Merritt Island, Florida, United States
- Local Institution - 1602 - Miami, Florida, United States
- Local Institution - 1618 - Miami, Florida, United States
- Hope Research Network - Miami - Miami, Florida, United States
- Local Institution - 1604 - Miami, Florida, United States
- Local Institution - 1608 - Ocala, Florida, United States
- Combined Research Orlando (CRO) - Orlando, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Local Institution - 1655 - Marrero, Louisiana, United States
- CBH Health - Gaithersburg, Maryland, United States
- Local Institution - 1663 - Foxborough, Massachusetts, United States
- Boston Center for Memory - Newton, Massachusetts, United States
- Mayflower Clinical Research - South Dartmouth, Massachusetts, United States
- Elixia MA - Springfield, Massachusetts, United States
- NeuroBehavioral Medicine Group - Bloomfield Hills, Michigan, United States
- Oakland Medical Research - Troy, Michigan, United States
- Redbird Research - Las Vegas, Nevada, United States
- Local Institution - 1647 - Middletown, New Jersey, United States
- Global Medical Institutes LLC; Princeton Medical Institute - Princeton, New Jersey, United States
- Local Institution - 1610 - Inwood, New York, United States
- Mid Hudson Medical Research - New Windsor, New York, United States
- Five Towns Neurology PC -Woodmere - 923 Broadway - Woodmere, New York, United States
- Local Institution - 1645 - Woodmere, New York, United States
- Central States Research - Tulsa, Oklahoma, United States
- Local Institution - 1652 - Columbia, South Carolina, United States
- Advanced Neurology Epilepsy and Sleep Center - El Paso, Texas, United States
- Wasatch Clinical Research, LLC - Salt Lake City, Utah, United States
- The Memory Clinic - Bennington, Vermont, United States
- Local Institution - 1644 - Seattle, Washington, United States
- Kingfisher Cooperative - Spokane, Washington, United States
- Eginition Hospital - Athens, Greece
- Athens Medical Center - Athens, Greece
- Local Institution - 1451 - Bucharest, Romania
- Local Institution - 1463 - Bucharest, Romania
- Local Institution - 1459 - Bucharest, Romania
- Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala - Bucharest, Romania
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) - Buenos Aires, Argentina
- Unidade Local de Saúde de Coimbra, E.P.E. - Coimbra, Portugal
- Cai Ferate Clinical Hospital Constanta - Constanța, Romania
- Instituto Privado Kremer - Córdoba, Argentina
- Centro Medico Luquez - Córdoba, Argentina
- Local Institution - 1256 - Delhi, India
- Hospital General Universitario de Elche - Elche (alicante), Spain
- Kuramitsu Hospital - Fukuoka, Japan
- Centro Hospitalar do Alto Ave - Guimarães, Portugal
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University - Hangzhou, China
- Local Institution - 1251 - Hyderabad, India
- Institutul de Psihiatrie Socola - Iași, Romania
- Local Institution - 1201 - Ioannina, Greece
- The First Affiliated Hospital of Kunming Medical University - Kunming, China
- Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria - Lisbon, Portugal
Showing 60 of 159 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →