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

Menü

Klinische Studien von BMS suchen
BMS-Symbol für "Studie, für die rekrutiert wird"

Recruiting

Studien-Nr. 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)

Zusammenfassung

  • Phase 3
  • Symbol für männliches und weibliches Geschlecht
  • 55-90
    Altersgruppe
  • 84
    Standorte
  • BMS-Symbol für "Studie, für die rekrutiert wird"
    Recruiting

Überblick

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.

Druckmedium-alt Druckmedium
email E-Mail

Nächstgelegenes Prüfzentrum

Wichtigste Einschlusskriterien

Einschlusskriterien

Symbol für Einschlusskriterien 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.

                            Ausschlusskriterien

                            Symbol für Ausschlusskriterien
                            :
                            • 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).
                                    Zusätzliche Informationen*
                                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                                      Behandlungsmöglichkeiten

                                      Studienarme

                                      ZUGEWIESENE BEHANDLUNG

                                      Studienarme

                                      Experimental: KarXT + KarX-EC

                                      ZUGEWIESENE BEHANDLUNG
                                      • Drug: Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule

                                      Studienarme

                                      Placebo Comparator: Placebo

                                      ZUGEWIESENE BEHANDLUNG
                                      • Drug: Placebo
                                      Prüfen Sie, ob eine der klinischen Studien für Sie infrage kommt
                                      Kommt die Studie für Sie infrage
                                      Beantworten Sie einige Fragen zu Ihrer Gesundheit, um festzustellen, ob diese Studie für Sie infrage kommt
                                      Geeignete Studie
                                      Wenn ihnen eine passende Studie angezeigt wird, klicken Sie auf die Studie, damit Sie die Liste der Prüfzentren angezeigt bekommen.
                                      Wählen Sie einen Prüfzentrumsstandort aus
                                      Wählen Sie einen Prüfzentrumsstandort aus, der für Sie günstig ist
                                      Registrieren
                                      Geben Sie Ihre Kontaktdaten ein, damit das Prüfzentrum mit Ihnen Kontakt aufnehmen kann.

                                      Unterstützen Sie uns dabei, Ihre Nutzung der Website zu optimieren! Teilen Sie Ihr Feedback mit unserem Team bei BMS Clinical Trials, um die Nutzung der Webseite, Ihre Erfahrungen und die anderer zu verbessern. Vielen Dank!