A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Part of paid clinical trials in Long Beach, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06976216
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- KarXT — DRUGSpecified dose on specified days
- KarX-EC — DRUGSpecified dose on specified days
- Placebo — OTHERSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Key Dates
- Start date
- Jul 14, 2025
- Status verified
- May 2026
- Primary completion
- Sep 11, 2028
- Completion
- Feb 23, 2029
Study Design
- Enrollment
- 586 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: KarXT + KarX-EC
- Placebo Comparator: Placebo
Primary Outcome Measure
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) [ Time Frame: At week 24 ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (28)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Healthy Brain Clinic | Long Beach | California | 90804 | Dung Trinh, Site 0173 562-606-5999 |
| Anderson Clinical Research | Redlands | California | 92374 | Donald Anderson, Site 0008 909-792-9007 |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | Alison Allen, Site 0025 970-927-1141 |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | Raymond Turner, Site 0024 202-687-7337 |
| JEM Research Institute | Atlantis | Florida | 33462 | Linda Pao, Site 0154 561-968-2933 |
| VIN-Julie Schwartzbard | Aventura | Florida | 33180 | Julie Schwartzbard, Site 0128 305-799-9459 |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | Wasim Niazi, Site 0023 386-785-8009 |
| Renstar Medical Research | Ocala | Florida | 34470 | Anette Nieves, Site 0055 352-629-5800 |
| Alzheimer's Research and Treatment Center | Stuart | Florida | 34997 | Adam Falchook, Site 0263 561-209-2400 |
| Charter Research - Lady Lake | The Villages | Florida | 32162 | Jeffrey Norton, Site 0184 352-775-1000 |
| Local Institution - 0016 | Columbus | Georgia | 31909 | - |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | Chris Recknor, Site 0125 770-630-9615 |
| Re:Cognition Health - Chicago | Chicago | Illinois | 60611 | Antonio Iglesias, Site 0109 312-971-3318 |
| Ascension Alexian Brothers | Elk Grove Village | Illinois | 60007 | Concetta Forchetti, Site 0054 847-593-8553 |
| Boston Center for Memory | Newton | Massachusetts | 02459 | Paul Solomon, Site 0009 413-281-0577 |
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | Marcel Hungs, Site 0110 111-111-1111 |
| Advanced Memory Research Institute of New Jersey | Toms River | New Jersey | 08755 | Arun Singh, Site 0123 732-341-9500 |
| Local Institution - 0259 | New York | New York | 10029 | - |
| NYU Langone Health | New York | New York | 10016 | Martin Sadowski, Site 0101 212-263-5708 |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | Sharon Brangman, Site 0202 315-436-0177 |
| AMC Research, LLC | Matthews | North Carolina | 28105 | Mohammad Bolouri, Site 0007 7043644000ext225 |
| Ohio State University | Columbus | Ohio | 43221 | Douglas Scharre, Site 0073 |
| NDx Clinical Research Inc. | Dayton | Ohio | 45459 | Joel Vandersluis, Site 0026 937-224-8200 |
| Summit Headlands | Portland | Oregon | 97210 | Scott Losk, Site 0067 503-279-8252 |
| Local Institution - 0004 | Abington | Pennsylvania | 19001 | - |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | john stoukides, Site 0056 401-435-8950 |
| Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | Thomas Arnold, Site 0099 901-866-9252 |
| Gadolin Research | Beaumont | Texas | 77702 | Joseph Oommen, Site 0018 409-331-6040 |
Find similar trials in Long Beach, CA
By condition
By specialty
Related Studies
- Dominantly Inherited Alzheimer Network (DIAN)Recruiting · Washington University School of Medicine · Jacksonville, Florida
- Imaging of Brain Amyloid Plaques in the Aging PopulationPHASE4 · Enrolling By Invitation · Mayo Clinic · Rochester, Minnesota
- PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric DiseasesPHASE1/PHASE2 · Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
- Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's DiseaseRecruiting · Douglas Scharre · Columbus, Ohio