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)

What this study 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 join (things the study team will check)

✅ 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 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. 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.
  • 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:
  • 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).

🚫 You may not be able to 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: 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 this trial is running

• 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

+ 146 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07011732.