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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. - 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

Healthy Brain Clinic
Long Beach 5367929, California 5332921 90804
Contact:
Dung Trinh, Site 0173
562-606-5999

Anderson Clinical Research
Redlands 5386754, California 5332921 92374
Contact:
Donald Anderson, Site 0008
909-792-9007

Mountain Neurological Research Center
Basalt 5412822, Colorado 5417618 81621
Contact:
Alison Allen, Site 0025
970-927-1141

JEM Research Institute
Atlantis 4146372, Florida 4155751 33462
Contact:
Linda Pao, Site 0154
561-968-2933

VIN-Julie Schwartzbard
Aventura 4146429, Florida 4155751 33180
Contact:
Julie Schwartzbard, Site 0128
305-799-9459

Merritt Island Medical Research, LLC
Merritt Island 4164092, Florida 4155751 32952
Contact:
Wasim Niazi, Site 0023
386-785-8009

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470
Contact:
Anette Nieves, Site 0055
352-629-5800

Alzheimer's Research and Treatment Center
Stuart 4174201, Florida 4155751 34997
Contact:
Adam Falchook, Site 0263
561-209-2400

Charter Research - Lady Lake
The Villages 4175179, Florida 4155751 32162
Contact:
Jeffrey Norton, Site 0184
352-775-1000

Center for Advanced Research & Education
Gainesville 4196586, Georgia 4197000 30501
Contact:
Chris Recknor, Site 0125
770-630-9615

Re:Cognition Health - Chicago
Chicago 4887398, Illinois 4896861 60611
Contact:
Antonio Iglesias, Site 0109
312-971-3318

Ascension Alexian Brothers
Elk Grove Village 4890925, Illinois 4896861 60007
Contact:
Concetta Forchetti, Site 0054
847-593-8553

Boston Center for Memory
Newton 4945283, Massachusetts 6254926 02459
Contact:
Paul Solomon, Site 0009
413-281-0577

HealthPartners Neuroscience Center
Saint Paul 5045360, Minnesota 5037779 55130
Contact:
Marcel Hungs, Site 0110
111-111-1111

Advanced Memory Research Institute of New Jersey
Toms River 4504476, New Jersey 5101760 08755
Contact:
Arun Singh, Site 0123
732-341-9500

Adams Clinical Harlem
New York 5128581, New York 5128638 10029
Contact:
Patricia Walsh, Site 0259
917-423-6797

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
Sharon Brangman, Site 0202
315-436-0177

AMC Research, LLC
Matthews 4478334, North Carolina 4482348 28105
Contact:
Mohammad Bolouri, Site 0007
7043644000ext225

Ohio State University
Columbus 4509177, Ohio 5165418 43221
Contact:
Douglas Scharre, Site 0073

Neurology Diagnostics, Inc.
Dayton 4509884, Ohio 5165418 45459
Contact:
Joel Vandersluis, Site 0026
937-224-8200

Summit Headlands
Portland 5746545, Oregon 5744337 97210
Contact:
Scott Losk, Site 0067
503-279-8252

Rhode Island Mood & Memory Research Institute
East Providence 5221931, Rhode Island 5224323 02914
Contact:
john stoukides, Site 0056
401-435-8950

Neurology Clinic, P.C.
Cordova 4050552, Tennessee 4662168 38018
Contact:
Thomas Arnold, Site 0099
901-866-9252

Gadolin Research
Beaumont 4672989, Texas 4736286 77702
Contact:
Joseph Oommen, Site 0018
409-331-6040

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
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.