RECRUITING

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

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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 2)

Quick Facts

Study Start:2025-07-21
Study Completion:2029-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976203

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)

Fullerton Neurology and Headache Center
Fullerton, California, 92835
United States
Local Institution - 0091
Inglewood, California, 90301
United States
Local Institution - 0095
Irvine, California, 92614
United States
Local Institution - 0083
Palo Alto, California, 94304
United States
Local Institution - 0069
San Diego, California, 92103
United States
Local Institution - 0088
Colorado Springs, Colorado, 80919
United States
Local Institution - 0090
Fort Myers, Florida, 33912
United States
Local Institution - 0086
Hallandale Beach, Florida, 33009
United States
Local Institution - 0092
Jacksonville, Florida, 32216
United States
Local Institution - 0114
Lady Lake, Florida, 32159
United States
Local Institution - 0082
Sarasota, Florida, 34239
United States
Local Institution - 0084
Tampa, Florida, 33613
United States
Local Institution - 0089
Wellington, Florida, 33414
United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
United States
Local Institution - 0070
Springfield, Illinois, 62702
United States
Local Institution - 0071
Indianapolis, Indiana, 46256
United States
Local Institution - 0080
Watertown, Massachusetts, 02472
United States
Local Institution - 0073
Farmington Hills, Michigan, 48334
United States
Local Institution - 0085
Hattiesburg, Mississippi, 39401
United States
Local Institution - 0119
Ridgewood, New Jersey, 07450
United States
Local Institution - 0094
Springfield, New Jersey, 07081
United States
Local Institution - 0075
West Long Branch, New Jersey, 07764
United States
Neurological Associates Albany
Albany, New York, 12208
United States
Local Institution - 0068
Amherst, New York, 14226
United States
Local Institution - 0087
Buffalo, New York, 14203
United States
Local Institution - 0078
Lake Success, New York, 11042
United States
Local Institution - 0105
Plymouth Meeting, Pennsylvania, 19462
United States
Local Institution - 0081
Dallas, Texas, 75231
United States
Local Institution - 0079
Round Rock, Texas, 78681
United States
Local Institution - 0076
Renton, Washington, 98057
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 Date2025-07-21
Study Completion Date2029-02-23

Study Record Updates

Study Start Date2025-07-21
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