Last updated 14 days ago
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)
352 patients around the world
Available in Puerto Rico, Chile, Argentina, United States
Bristol-Myers Squibb
12Research sites
352Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 90 Years
All Gender
Medical requirements
- 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.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.A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one of 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.Attend all visits and report on participant's status.Oversee participant compliance with medication and study procedures.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).CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).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 or more aggressive behaviors occurring several times per week.2 or more aggressive behaviors occurring once or twice per week.3 or more aggressive behaviors occurring less than once per week.
- Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.History of bipolar disorder, schizophrenia, or schizoaffective disorder.History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.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).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.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.
Sites
I'm a patient
I'm a referring doctor
Instituto Modelo de Neurología Lennox
Recruiting
CENYDET Centro Neurobiológico y de Estrés Traumático (Biopsychomedical Research Group S.R.L.)
Recruiting
Instituto Médico Damic S.R.L.
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
Recruiting
Resolution Psychopharmacology Research Institute
Recruiting
Sanatorio Privado Prof. Leon S Morra S.A.
Recruiting
Biomedica Research Group
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
Clínica Alemana - Chile
Recruiting
Choose your role
I'm a patient
I'm a referring doctor
StudyADAGIO-2
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Alzheimer disease
Requirements
To 90 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07011745
