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-1)

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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:2028-12-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07011732

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 - 1619
Scottsdale, Arizona, 85258
United States
Local Institution - 1657
Anaheim, California, 92805
United States
Local Institution - 1637
La Jolla, California, 92037
United States
Local Institution - 1662
Pomona, California, 91767
United States
Local Institution - 1639
Torrance, California, 90505
United States
Local Institution - 1651
Walnut Creek, California, 94596
United States
Local Institution - 1630
Colorado Springs, Colorado, 80907
United States
Local Institution - 1622
Maitland, Florida, 32751
United States
Local Institution - 1631
Maitland, Florida, 32751
United States
Local Institution - 1618
Miami, Florida, 33135
United States
Local Institution - 1609
Miami, Florida, 33166
United States
Local Institution - 1604
Miami, Florida, 33186
United States
Local Institution - 1608
Ocala, Florida, 34471
United States
Local Institution - 1635
Orlando, Florida, 32807
United States
Local Institution - 1612
Port Orange, Florida, 32127
United States
Local Institution - 1661
Savannah, Georgia, 31406
United States
Local Institution - 1655
Marrero, Louisiana, 70072
United States
CBH Health
Gaithersburg, Maryland, 20877
United States
Local Institution - 1638
Newton, Massachusetts, 02459-3328
United States
Local Institution - 1642
South Dartmouth, Massachusetts, 02747
United States
Local Institution - 1660
Springfield, Massachusetts, 01151
United States
Local Institution - 1620
Troy, Michigan, 48085
United States
Local Institution - 1649
Las Vegas, Nevada, 89119
United States
Local Institution - 1647
Middletown, New Jersey, 07748
United States
Local Institution - 1610
Inwood, New York, 11096
United States
Local Institution - 1656
New Windsor, New York, 12553
United States
Local Institution - 1645
Woodmere, New York, 11598-1739
United States
Local Institution - 1658
Woodmere, New York, 11598-1739
United States
Local Institution - 1601
Monroe, North Carolina, 28112
United States
Local Institution - 1659
Centerville, Ohio, 45459
United States
Central States Research
Tulsa, Oklahoma, 74136
United States
Local Institution - 1652
Columbia, South Carolina, 29205
United States
Local Institution - 1653
Columbia, South Carolina, 29205
United States
Local Institution - 1643
El Paso, Texas, 79912
United States
Local Institution - 1641
Salt Lake City, Utah, 84107
United States
Local Institution - 1646
Bennington, Vermont, 05201-9810
United States
Local Institution - 1644
Seattle, Washington, 98122
United States
Local Institution - 1654
Spokane, Washington, 99201
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 Date2028-12-08

Study Record Updates

Study Start Date2025-07-18
Study Completion Date2028-12-08

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease