RECRUITING

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

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Conditions

Alzheimer's DiseaseDementiaCognitive ImpairmentKar-XTKarX-ECMild Alzheimer's DiseaseModerate Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)

Quick Facts

Study Start:2025-07-14
Study Completion:2029-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site#
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0173
Long Beach, California, 90804
United States
Local Institution - 0008
Redlands, California, 92374
United States
Local Institution - 0025
Basalt, Colorado, 81621
United States
Local Institution - 0024
Washington, District of Columbia, 20007
United States
Local Institution - 0154
Atlantis, Florida, 33462
United States
Local Institution - 0128
Aventura, Florida, 33180
United States
Local Institution - 0023
Merritt Island, Florida, 32952
United States
Local Institution - 0055
Ocala, Florida, 34470
United States
Local Institution - 0263
Stuart, Florida, 34997
United States
Local Institution - 0184
The Villages, Florida, 32162
United States
Local Institution - 0016
Columbus, Georgia, 31909
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
Local Institution - 0109
Chicago, Illinois, 60611
United States
Local Institution - 0054
Elk Grove Village, Illinois, 60007
United States
Boston Center for Memory
Newton, Massachusetts, 02459
United States
Local Institution - 0110
Saint Paul, Minnesota, 55130
United States
Local Institution - 0123
Toms River, New Jersey, 08755
United States
Local Institution - 0101
New York, New York, 10016
United States
Local Institution - 0259
New York, New York, 10029
United States
Local Institution - 0202
Syracuse, New York, 13210
United States
Local Institution - 0007
Charlotte, North Carolina, 28270
United States
Local Institution - 0073
Columbus, Ohio, 43221
United States
Local Institution - 0026
Dayton, Ohio, 45459
United States
Local Institution - 0067
Portland, Oregon, 97210
United States
Local Institution - 0004
Abington, Pennsylvania, 19001
United States
Local Institution - 0056
East Providence, Rhode Island, 02914
United States
Local Institution - 0099
Cordova, Tennessee, 38018
United States
Local Institution - 0152
Knoxville, Tennessee, 37909
United States
Local Institution - 0018
Beaumont, Texas, 77702
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2029-02-23

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2029-02-23

Terms related to this study

Keywords Provided by Researchers

  • Dementia
  • Cognitive Impairment
  • Kar-XT
  • KarX-EC
  • Mild Alzheimer's Disease
  • Moderate Alzheimer's Disease

Additional Relevant MeSH Terms

  • Alzheimer's Disease