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)
Sponsored by Bristol-Myers Squibb
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.
Where this study is enrolling (19)
- I'm interested
Imaging Endpoints
Scottsdale, Arizona
- Call 714-999-6688
Advanced Research Center (ARC) - Anaheim
Anaheim, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 925-298-5147
Sunwise Clinical Research
Walnut Creek, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 786-681-4959
Hope Research Network - Miami
Miami, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 321-305-5015
Flourish Research
Merritt Island, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Show all 19 locations
- Call 386-304-7070
Progressive Medical Research
Port Orange, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 407-440-4493
Combined Research Orlando (CRO)
Orlando, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 301-251-4702
CBH Health
Gaithersburg, Maryland
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 413-281-0577
Boston Center for Memory
Newton, Massachusetts
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 508-925-7403
Mayflower Clinical Research
South Dartmouth, Massachusetts
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 412-916-2425
NeuroBehavioral Medicine Group
Bloomfield Hills, Michigan
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 248-687-7412
Oakland Medical Research
Troy, Michigan
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 760-758-2222
Redbird Research
Las Vegas, Nevada
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 845-674-9398
Mid Hudson Medical Research
New Windsor, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 516-239-1800
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 918-645-5400
Central States Research
Tulsa, Oklahoma
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 505-903-1715
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 801-288-0607
Wasatch Clinical Research, LLC
Salt Lake City, Utah
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 413-281-0575
The Memory Clinic
Bennington, Vermont
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Who can participate
Inclusion criteria
- ✓\- 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 ≤ 24 at Screening (Visit 1).
- ✓Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) 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.
- ✓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).
- ✓CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).
Exclusion criteria
- ✕\- 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. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
- ✕C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- ✕\- Other protocol-defined Inclusion/Exclusion criteria apply.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.