A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Recruiting · NCT07011745 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Alzheimer's Disease

Interventions studied

PlaceboXanomeline Enteric CapsuleXanomeline/Trospium Chloride Capsule

What this trial is about

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.

Who can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 20 US states.

Chandler Clinical Trials, LLC - Chandler, Arizona, United States
Local Institution - 2631 - Chandler, Arizona, United States
TrialSphere Corp - Chandler, Arizona, United States
National Institute of Clinical Research - Garden Grove, California, United States
Local Institution - 2607 - Long Beach, California, United States
Accellacare - Long Beach, California, United States
Local Institution - 2627 - Napa, California, United States
ATP Clinical Research - Orange, California, United States
Local Institution - 2613 - Pasadena, California, United States
Local Institution - 2614 - San Diego, California, United States
Local Institution - 2620 - West Hills, California, United States
Local Institution - 2601 - Basalt, Colorado, United States
Local Institution - 2632 - Norwalk, Connecticut, United States
Local Institution - 2648 - Aventura, Florida, United States
Envision Trials LLC - Bonita Springs, Florida, United States
Key Clinical Research - Bradenton, Florida, United States
Local Institution - 2636 - Doral, Florida, United States
Local Institution - 2606 - Homestead, Florida, United States
Miami Jewish health - Miami, Florida, United States
Local Institution - 2637 - Miami, Florida, United States
Local Institution - 2634 - Orlando, Florida, United States
IPTB Clinical Research - Tampa, Florida, United States
Agile Clinical Research Trials, LLC - Atlanta, Georgia, United States
Local Institution - 2615 - Worcester, Massachusetts, United States
Local Institution - 2618 - Ann Arbor, Michigan, United States
Local Institution - 2630 - Saint Paul, Minnesota, United States
Hattiesburg Clinic - Hattiesburg, Mississippi, United States
Local Institution - 2603 - Ozark, Missouri, United States
Las Vegas Clinical Trials - Las Vegas, Nevada, United States
Local Institution - 2650 - Toms River, New Jersey, United States
Local Institution - 2647 - Brooklyn, New York, United States
Richmond Behavioral Associates - Staten Island, New York, United States
Walnut Clinical Research - Valley Stream, New York, United States
West Clinical Research - Morehead City, North Carolina, United States
Velocity Clinical Research - Blue Ash - Blue Ash, Ohio, United States
Epic Medical Research, LLC - Carrolton - Carrollton, Texas, United States
Horizon Clinical Research Center - Houston - Cypress, Texas, United States
Epic Medical Research, LLC - Mesquite - Mesquite, Texas, United States
UT Health - San Antonio - San Antonio, Texas, United States
Local Institution - 2612 - Bountiful, Utah, United States
EvergreenHealth Medical Center - Kirkland, Washington, United States
Local Institution - 2610 - Milwaukee, Wisconsin, United States
Psicomed Estudios Médicos Cía Ltda - Antofagasta, Chile
Azienda Ospedaliera Spedali Civili di Brescia - Brescia, Italy
Local Institution - 2256 - Budapest, Hungary
Local Institution - 2255 - Budapest, Hungary
Local Institution - 2251 - Budapest, Hungary
Semmelweis Egyetem - Budapest, Hungary
Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM - Buenos Aires, Argentina
Hospital Italiano de Buenos Aires (HIBA) - Buenos Aires, Argentina
Local Institution - 2502 - Cambridge, United Kingdom
NEUROHK - Choceň, Czechia
M2M Med - Chorzów, Poland
Instituto Modelo de Neurología, Fundación Lennox - Córdoba, Argentina
Sanatorio Morra S.A. - Córdoba, Argentina
Instituto Médico DAMIC - Córdoba, Argentina
Local Institution - 2201 - Düsseldorf, Germany
Local Institution - 2205 - Halle, Germany
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)" - Hlevakha, Ukraine
Gachon University Gil Medical Center - Incheon, South Korea

Showing 60 of 144 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →