RECRUITING

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

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Conditions

Alzheimer 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 in adult participants with agitation related to Alzheimer's Disease.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Quick Facts

Study Start:2025-07-18
Study Completion:2028-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07011745

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:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Amyloid PET.
  2. * Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
  3. * Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
  4. * Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:.
  5. * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
  6. * AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
  7. * CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
  8. * At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):.
  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
855-907-3286
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 - 2609
Chandler, Arizona, 85224-6231
United States
Local Institution - 2631
Chandler, Arizona, 85226-3732
United States
Local Institution - 2625
Long Beach, California, 90040
United States
Local Institution - 2607
Long Beach, California, 90805
United States
Local Institution - 2627
Napa, California, 94558
United States
Local Institution - 2613
Pasadena, California, 91105
United States
Local Institution - 2614
San Diego, California, 92108
United States
Local Institution - 2620
West Hills, California, 91307
United States
Local Institution - 2601
Basalt, Colorado, 81621
United States
Local Institution - 2635
Colorado Springs, Colorado, 80907
United States
Local Institution - 2632
Norwalk, Connecticut, 06851
United States
Local Institution - 2602
Bonita Springs, Florida, 34134-4154
United States
Local Institution - 2636
Doral, Florida, 33122
United States
Local Institution - 2626
Hialeah, Florida, 33012
United States
Local Institution - 2606
Homestead, Florida, 33032
United States
Local Institution - 2624
Maitland, Florida, 32751
United States
Local Institution - 2633
Miami, Florida, 33137
United States
Local Institution - 2637
Miami, Florida, 33165
United States
Local Institution - 2634
Orlando, Florida, 32806
United States
Local Institution - 2621
Tampa, Florida, 33629
United States
Local Institution - 2611
Atlanta, Georgia, 30328
United States
Local Institution - 2615
Worcester, Massachusetts, 01608
United States
Local Institution - 2618
Ann Arbor, Michigan, 48105
United States
Local Institution - 2630
Saint Paul, Minnesota, 55130
United States
Local Institution - 2629
Hattiesburg, Mississippi, 39402
United States
Local Institution - 2603
Ozark, Missouri, 65721
United States
Local Institution - 2628
Las Vegas, Nevada, 89030
United States
Local Institution - 2619
Staten Island, New York, 10312
United States
Local Institution - 2608
Morehead City, North Carolina, 28557
United States
Local Institution - 2617
Blue Ash, Ohio, 45242
United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, 75006
United States
Local Institution - 2605
Cypress, Texas, 77429
United States
Epic Medical Research, LLC - Mesquite
Mesquite, Texas, 75150
United States
Local Institution - 2623
San Antonio, Texas, 78229
United States
Local Institution - 2612
Bountiful, Utah, 84010
United States
Local Institution - 2610
Milwaukee, Wisconsin, 53226
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 Date2025-07-18
Study Completion Date2028-11-13

Study Record Updates

Study Start Date2025-07-18
Study Completion Date2028-11-13

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease