A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Purpose
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Condition
- Alzheimer's Disease
Eligibility
- Eligible Ages
- Between 60 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator KarXT + KarX-EC |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Fullerton, California 92835
Jack Florin, Site 0072
714-381-0801
Irvine, California 92614
Elly Lee, Site 0095
949-753-1663
Los Angeles, California 90056
Edward Zamrini, Site 0091
706-863-9595
Palo Alto, California 94304
Sharon Sha, Site 0083
000-000-0000
Colorado Springs, Colorado 80919
Adam Wolff, Site 0088
303-715-9024
Fort Myers, Florida 33912
Jennifer Springer, Site 0090
239-939-7777
Jacksonville, Florida 32216
Steven Toenjes, Site 0092
904-673-1252
Lady Lake, Florida 32159
Craig Curtis, Site 0114
407-426-9299
Sarasota, Florida 34239
Mauricio Concha, Site 0082
941-203-3750
Tampa, Florida 33613
Amanda Smith, Site 0084
813-974-4355
Wellington, Florida 33414
David Watson, Site 0089
561-209-2400
Chicago, Illinois 60640
Jeffrey Ross, Site 0093
847-252-7300
Springfield, Illinois 62702
Jennifer Arnold, Site 0070
217-545-7197
Indianapolis, Indiana 46256
Kristi George, Site 0071
317-537-6088
Farmington Hills, Michigan 48334
Aaron Ellenbogen, Site 0073
248-957-8940
Hattiesburg, Mississippi 39401
Ronald Schwartz, Site 0085
601-606-0911
Springfield, New Jersey 07081
Raminder Parihar, Site 0094
973-850-4622
West Long Branch, New Jersey 07764
Mark Ornstein, Site 0075
732-807-4700
Albany, New York 12208
Richard Holub, Site 0077
518-426-0575
Amherst, New York 14226
Horacio Capote, Site 0068
716-250-2000
Buffalo, New York 14203
Kinga Szigeti, Site 0087
281-630-2316
Plymouth Meeting, Pennsylvania 19462
Cameron Olezene, Site 0105
610-277-8073
Round Rock, Texas 78681
Elizabeth Peckham, Site 0079
443-852-2085
Renton, Washington 98057
Sheryl Marks, Site 0076
425-251-1722
Bayamón, Puerto Rico 00961
William Julio, Site 0074
7872208097
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com