A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
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)
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TrialSphere Corp
Chandler, Arizona
- Call 480-382-7909
Chandler Clinical Trials, LLC
Chandler, Arizona
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- Call 949-354-5353
ATP Clinical Research
Orange, California
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- Call +61736460818
Key Clinical Research
Bradenton, Florida
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- Call 305-819-2909
Envision Trials LLC
Bonita Springs, Florida
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Show all 19 locations
- Call 813-251-1800
IPTB Clinical Research
Tampa, Florida
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- Call 3057518626x2403
Miami Jewish health
Miami, Florida
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Agile Clinical Research Trials, LLC
Atlanta, Georgia
- Call 601-606-0911
Hattiesburg Clinic
Hattiesburg, Mississippi
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- Call 702-637-3223
Las Vegas Clinical Trials
Las Vegas, Nevada
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- Call 718-407-0225
Walnut Clinical Research
Valley Stream, New York
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- Call 718-619-4403
Richmond Behavioral Associates
Staten Island, New York
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- Call 252-515-0050
West Clinical Research
Morehead City, North Carolina
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- Call 513-769-2767
Velocity Clinical Research - Blue Ash
Blue Ash, Ohio
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- Call 949-491-0710
Horizon Clinical Research Center - Houston
Cypress, Texas
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- Call 972-782-2405
Epic Medical Research, LLC - Carrolton
Carrollton, Texas
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- Call 972-777-6956
Epic Medical Research, LLC - Mesquite
Mesquite, Texas
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- Call 210-567-8229
UT Health - San Antonio
San Antonio, Texas
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- Call 425-899-3123
EvergreenHealth Medical Center
Kirkland, Washington
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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).
- ✓Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and 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).
- ✕Note: 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.