Tests KarXT with KarX-EC for agitation in Alzheimer's disease
Tests KarXT with KarX-EC against placebo in adults with Alzheimer's-related agitation.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Key facts
- Where
- Düsseldorf, Halle, and Westerstede, GermanySee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
- Has a doctor told you that you have Alzheimer's disease?
- Do you have agitation caused by Alzheimer's disease, such as being restless or aggressive?
- Do you have a caregiver or trial partner who sees you regularly and can help with the study?
- Has a doctor ever told you that you have bipolar disorder, schizophrenia or schizoaffective disorder?
Source: NCT07011745, who can take part
Where in Germany
- DüsseldorfDüsseldorf, GermanyNot yet recruiting
- HalleHalle, GermanyNot yet recruiting
- WesterstedeWesterstede, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07011745EU 2025-520612-34-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)
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.
Inclusion: 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; If no historical evidence available:; 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 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:; 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); Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and Visit 2.
Exclusion: Prior/Concomitant Therapy; 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; Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1); Note: Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1); Medical Conditions; 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; Other protocol-defined Inclusion/Exclusion criteria apply.