Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Recruiting Study icon

Recruiting

Trial ID CN012-0024  |   NCT07011745

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-2)

Summary

  • Phase 3
  • Male and Female Gender icon
  • 55-90
    Age Range
  • 81
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

print Print
email Email

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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:.
    1. 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.
      1. If no historical evidence available:.
        1. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
        2. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:.
    2. Amyloid PET.
      1. Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
        1. Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
          1. Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:.
            1. Attend all visits and report on participant's status.
              1. Oversee participant compliance with medication and study procedures.
                1. Participate in the study assessments and provide informed consent to participate in the study.
                2. 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).
                  1. AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
                    1. CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
                      1. At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):.
                        1. 1 or more aggressive behaviors occurring several times per week.
                          1. 2 or more aggressive behaviors occurring once or twice per week.
                            1. 3 or more aggressive behaviors occurring less than once per week.

                            Exclusion Criteria

                            Exclusion Criteria Icon
                            :
                            • Medical Conditions.
                              1. Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
                                1. History of bipolar disorder, schizophrenia, or schizoaffective disorder.
                                  1. History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
                                    1. Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
                                    2. Prior/Concomitant Therapy.
                                      1. 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).
                                        1. 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.
                                        2. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
                                    Additional Information *
                                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                                      Treatment Options

                                      Study Arms

                                      ASSIGNED INTERVENTION

                                      Study Arms

                                      Experimental: KarXT + KarX-EC

                                      ASSIGNED INTERVENTION
                                      • Drug: Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule

                                      Study Arms

                                      Placebo Comparator: Placebo

                                      ASSIGNED INTERVENTION
                                      • Drug: Placebo
                                      Take the first step to see if you Match to a Clinical Trial – Check if you qualify
                                      Check if you qualify
                                      Answer some questions about Your health to see if you may match to this trial
                                      Match to a Trial
                                      If you are a match, click on the study to see the list of study site locations
                                      Select a Study Site Location
                                      Select a study site location that is convenient for you
                                      Register
                                      Provide your contact details for the study site to connect with you.

                                      Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you