RecruitingAlzheimer Disease

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)

Eligible age

55–90 yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Bristol-Myers Squibb

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 5 to 22, inclusive, at Screening (Visit 1).
✓ Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) 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.

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. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
✕ \- Other protocol-defined Inclusion/Exclusion criteria apply.