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)

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.

Conditions

Alzheimer Disease
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Related Conditions:

Alzheimer Disease

Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Local Institution - 1619, Scottsdale, Arizona, United States, 85258

Anaheim

Local Institution - 1657, Anaheim, California, United States, 92805

La Jolla

Local Institution - 1637, La Jolla, California, United States, 92037

Pomona

Local Institution - 1662, Pomona, California, United States, 91767

Torrance

Local Institution - 1639, Torrance, California, United States, 90505

Walnut Creek

Local Institution - 1651, Walnut Creek, California, United States, 94596

Colorado Springs

Local Institution - 1630, Colorado Springs, Colorado, United States, 80907

Maitland

Local Institution - 1622, Maitland, Florida, United States, 32751

Maitland

Local Institution - 1631, Maitland, Florida, United States, 32751

Miami

Local Institution - 1618, Miami, Florida, United States, 33135

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Amyloid PET.
  • * Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
  • * Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
  • * Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:.
  • * 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).
  • * AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
  • * CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
  • * 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):.

Ages Eligible for Study

55 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2028-12-08