Clinical Trials in Italy / NCT06976203
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
NCT06976203 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Alzheimer's Disease
Investigational drug(s) / intervention(s)
KarXT: Specified dose on specified days
KarX-EC: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Eligibility
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.
Primary outcome measure(s)
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) — At week 24
- Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) — At week 24
Trial sites (127)
| Facility | City | Region | Status |
|---|---|---|---|
| Fullerton Neurology and Headache Center | Fullerton | California | Recruiting |
| Irvine Clinical Research | Irvine | California | Recruiting |
| Inglewood Clinical | Los Angeles | California | Recruiting |
| Stanford Neuroscience Health Center | Palo Alto | California | Recruiting |
| Local Institution - 0069 | San Diego | California | Withdrawn |
| Research of the Rockies | Colorado Springs | Colorado | Recruiting |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | Recruiting |
| Local Institution - 0086 | Hallandale | Florida | Completed |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | Recruiting |
| K2 MEDICAL Research THE VILLAGES | Lady Lake | Florida | Recruiting |
| Intercoastal Medical Group | Sarasota | Florida | Recruiting |
| USF Health Byrd Alzheimer's Institute | Tampa | Florida | Recruiting |
| Local Institution - 0129 | The Villages | Florida | Not Yet Recruiting |
| Alzheimer's Research and Treatment Center | Wellington | Florida | Recruiting |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | Recruiting |
| Southern Illinois University School of Medicine | Springfield | Illinois | Recruiting |
| Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | Recruiting |
| Local Institution - 0080 | Watertown | Massachusetts | Not Yet Recruiting |
| QUEST Research Institute | Farmington Hills | Michigan | Recruiting |
| Private Practice - Dr. Ronald Louis Schwartz | Hattiesburg | Mississippi | Recruiting |
| Local Institution - 0119 | Ridgewood | New Jersey | Withdrawn |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | Recruiting |
| Advanced Clinical Institute | West Long Branch | New Jersey | Recruiting |
| Neurological Associates Albany | Albany | New York | Recruiting |
| Dent Neurosciences Research Center, Inc | Amherst | New York | Recruiting |
| University at Buffalo - UBMD Neurology | Buffalo | New York | Recruiting |
| Local Institution - 0078 | Lake Success | New York | Withdrawn |
| Keystone Clinical Studies | Plymouth Meeting | Pennsylvania | Recruiting |
| Local Institution - 0081 | Dallas | Texas | Not Yet Recruiting |
| Central Texas Neurology Consultants, PA | Round Rock | Texas | Recruiting |
| Local Institution - 0076 | Renton | Washington | Completed |
| Hospital Italiano de Buenos Aires | ABB | Buenos Aires F.D. | Recruiting |
| Centro Médico Luquez | Córdoba | Córdoba Province | Recruiting |
| Local Institution - 0025 | Buenos Aires | Argentina | Not Yet Recruiting |
| CEN Centro Especializado en Neurociencias | Córdoba | Argentina | Recruiting |
| Instituto Médico DAMIC | Córdoba | Argentina | Recruiting |
| Resolution Psychopharmacology Research Institute | Mendoza | Argentina | Recruiting |
| University of the Sunshine Coast Birtinya | Birtinya | Queensland | Recruiting |
| Local Institution - 0055 | Herston (rbwh Grounds) | Queensland | Not Yet Recruiting |
| Griffith University - Gold Coast Campus | Southport | Queensland | Recruiting |
+ 87 more sites — see the full list on the official registry below.
More Bristol-Myers Squibb trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06976203 on ClinicalTrials.gov ↗ ← All trials in Italy