Print

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

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

ArmDescriptionAssigned Intervention
Active Comparator
KarXT + KarX-EC
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
  • Drug: KarX-EC
    Specified dose on specified days
    Other names:
    • BMS-986519
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

Fullerton Neurology and Headache Center
Fullerton, California 92835
Contact:
Jack Florin, Site 0072
714-381-0801

Irvine Clinical Research
Irvine, California 92614
Contact:
Elly Lee, Site 0095
949-753-1663

Inglewood Clinical
Los Angeles, California 90056
Contact:
Edward Zamrini, Site 0091
706-863-9595

Stanford Neuroscience Health Center
Palo Alto, California 94304
Contact:
Sharon Sha, Site 0083
000-000-0000

Research of the Rockies
Colorado Springs, Colorado 80919
Contact:
Adam Wolff, Site 0088
303-715-9024

Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Contact:
Jennifer Springer, Site 0090
239-939-7777

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Contact:
Steven Toenjes, Site 0092
904-673-1252

K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
Contact:
Craig Curtis, Site 0114
407-426-9299

Intercoastal Medical Group
Sarasota, Florida 34239
Contact:
Mauricio Concha, Site 0082
941-203-3750

USF Health Byrd Alzheimer's Institute
Tampa, Florida 33613
Contact:
Amanda Smith, Site 0084
813-974-4355

Alzheimer's Research and Treatment Center
Wellington, Florida 33414
Contact:
David Watson, Site 0089
561-209-2400

Great Lakes Clinical Trials - Andersonville
Chicago, Illinois 60640
Contact:
Jeffrey Ross, Site 0093
847-252-7300

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Jennifer Arnold, Site 0070
217-545-7197

Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana 46256
Contact:
Kristi George, Site 0071
317-537-6088

QUEST Research Institute
Farmington Hills, Michigan 48334
Contact:
Aaron Ellenbogen, Site 0073
248-957-8940

Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi 39401
Contact:
Ronald Schwartz, Site 0085
601-606-0911

The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
Contact:
Raminder Parihar, Site 0094
973-850-4622

Advanced Clinical Institute
West Long Branch, New Jersey 07764
Contact:
Mark Ornstein, Site 0075
732-807-4700

Neurological Associates Albany
Albany, New York 12208
Contact:
Richard Holub, Site 0077
518-426-0575

Dent Neurosciences Research Center, Inc
Amherst, New York 14226
Contact:
Horacio Capote, Site 0068
716-250-2000

University at Buffalo - UBMD Neurology
Buffalo, New York 14203
Contact:
Kinga Szigeti, Site 0087
281-630-2316

Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462
Contact:
Cameron Olezene, Site 0105
610-277-8073

Central Texas Neurology Consultants, PA
Round Rock, Texas 78681
Contact:
Elizabeth Peckham, Site 0079
443-852-2085

Rainier Clinical Research Center
Renton, Washington 98057
Contact:
Sheryl Marks, Site 0076
425-251-1722

SCB Research Center
Bayamón, Puerto Rico 00961
Contact:
William Julio, Site 0074
7872208097

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.