A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Recruiting · NCT06976203 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Who can take part
Age range
60 Years to 85 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
- Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
- Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
- Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
- Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Exclusion criteria
- Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
- Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
- Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
- Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 13 US states.
- Fullerton Neurology and Headache Center - Fullerton, California, United States
- Irvine Clinical Research - Irvine, California, United States
- Inglewood Clinical - Los Angeles, California, United States
- Stanford Neuroscience Health Center - Palo Alto, California, United States
- Local Institution - 0069 - San Diego, California, United States
- Research of the Rockies - Colorado Springs, Colorado, United States
- Neuropsychiatric Research Center of Southwest Florida - Fort Myers, Florida, United States
- Local Institution - 0086 - Hallandale, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- K2 MEDICAL Research THE VILLAGES - Lady Lake, Florida, United States
- Intercoastal Medical Group - Sarasota, Florida, United States
- USF Health Byrd Alzheimer's Institute - Tampa, Florida, United States
- Local Institution - 0129 - The Villages, Florida, United States
- Alzheimer's Research and Treatment Center - Wellington, Florida, United States
- Great Lakes Clinical Trials - Andersonville - Chicago, Illinois, United States
- Southern Illinois University School of Medicine - Springfield, Illinois, United States
- Josephson Wallack Munshower Neurology, PC - Indianapolis, Indiana, United States
- Local Institution - 0080 - Watertown, Massachusetts, United States
- QUEST Research Institute - Farmington Hills, Michigan, United States
- Private Practice - Dr. Ronald Louis Schwartz - Hattiesburg, Mississippi, United States
- Local Institution - 0119 - Ridgewood, New Jersey, United States
- The Cognitive and Research Center of New Jersey - Springfield, New Jersey, United States
- Advanced Clinical Institute - West Long Branch, New Jersey, United States
- Neurological Associates Albany - Albany, New York, United States
- Dent Neurosciences Research Center, Inc - Amherst, New York, United States
- University at Buffalo - UBMD Neurology - Buffalo, New York, United States
- Local Institution - 0078 - Lake Success, New York, United States
- Keystone Clinical Studies - Plymouth Meeting, Pennsylvania, United States
- Local Institution - 0081 - Dallas, Texas, United States
- Central Texas Neurology Consultants, PA - Round Rock, Texas, United States
- Local Institution - 0076 - Renton, Washington, United States
- Private Practice - Dr. Irma Schöll - Bad Homburg, Germany
- SCB Research Center - Bayamón, Puerto Rico
- Re:Cognition Health - Birmingham - Birmingham, United Kingdom
- Bordeaux University Hospital - Pellegrin - Bordeaux, France
- Hospital de Braga - Braga, Portugal
- Local Institution - 0042 - Bucharest, Romania
- Local Institution - 0025 - Buenos Aires, Argentina
- Pharmakologisches Studienzentrum Chemnitz - Chemnitz, Germany
- Unidade Local de Saúde de Coimbra, E.P.E. - Coimbra, Portugal
- Universitaetsklinikum Koeln - Cologne, Germany
- CEN Centro Especializado en Neurociencias - Córdoba, Argentina
- Instituto Médico DAMIC - Córdoba, Argentina
- Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia - Foggia, Italy
- Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira - Guimarães, Portugal
- Terveystalo Ruoholahti - Helsinki, Finland
- Itä-Suomen Yliopisto Kuopio - Kuopio, Finland
- Local Institution - 0107 - Kyoto, Japan
- Leeds and York Partnership NHS Foundation Trust - Leeds, United Kingdom
- Complejo Hospitalario Ruber Juan Bravo - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Resolution Psychopharmacology Research Institute - Mendoza, Argentina
- NeuroClin Glasgow - Motherwell, United Kingdom
- Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière - Paris, France
- Hôpital Broca - Paris, France
- Pitie Salpetriere University Hospital - Paris, France
- Centro Hospitalar do Porto - Hospital de Santo António - Porto, Portugal
- Ruschel Medicina e Pesquisa Clínica - Rio de Janeiro, Brazil
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore - Roma, Italy
- Spitalul de Psihiatrie și Neurologie Brașov - Sanpetru /Brasov, Romania
Showing 60 of 127 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →