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 now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT07011732

Run by

Bristol-Myers Squibb

People needed

426

Starts

2025-07-10

Expected to finish

2028-12-08

Last updated by the study team

2026-07-13

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify 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.
• 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).

You may not qualify 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 it is running

• Wasatch Clinical Research, LLC — Salt Lake City, Utah, United States (enrolling)
• Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina (enrolling)
• Mid Hudson Medical Research — New Windsor, New York, United States (enrolling)
• Advanced Neurology Epilepsy and Sleep Center — El Paso, Texas, United States (enrolling)
• The Memory Clinic — Bennington, Vermont, United States (enrolling)
• CEN Centro Especializado en Neurociencias — Córdoba, Córdoba Province, Argentina (enrolling)
• The Neurology Group — Pomona, California, United States (enrolling)
• Global Medical Institutes LLC; Princeton Medical Institute — Princeton, New Jersey, United States (enrolling)
• Five Towns Neurology PC -Woodmere - 923 Broadway — Woodmere, New York, United States (enrolling)
• Central States Research — Tulsa, Oklahoma, United States (enrolling)
• Sunwise Clinical Research — Walnut Creek, California, United States (enrolling)
• Hope Research Network - Miami — Miami, Florida, United States (enrolling)
• Imaging Endpoints — Scottsdale, Arizona, United States (enrolling)
• Kingfisher Cooperative — Spokane, Washington, United States (enrolling)
• Combined Research Orlando (CRO) — Orlando, Florida, United States (enrolling)
• Progressive Medical Research — Port Orange, Florida, United States (enrolling)
• Redbird Research — Las Vegas, Nevada, United States (enrolling)
• CBH Health — Gaithersburg, Maryland, United States (enrolling)
• Advanced Research Center (ARC) - Anaheim — Anaheim, California, United States (enrolling)
• Boston Center for Memory — Newton, Massachusetts, United States (enrolling)
• Mayflower Clinical Research — South Dartmouth, Massachusetts, United States (enrolling)
• Elixia MA — Springfield, Massachusetts, United States (enrolling)
• NeuroBehavioral Medicine Group — Bloomfield Hills, Michigan, United States (enrolling)
• Oakland Medical Research — Troy, Michigan, United States (enrolling)
• Instituto Privado Kremer — Córdoba, Argentina (enrolling)

Full record on ClinicalTrials.gov

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