A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Purpose

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Conditions

  • Alzheimer Disease
  • Agitation

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have completed study CN012-0023 or CN012-0024 per protocol. - Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).

Exclusion Criteria

  • Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT+KarX-EC
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • Xanomeline and Trospium Chloride capsule, BMS-986510
  • Drug: KarX-EC
    Specified dose on specified days
    Other names:
    • Xanomeline enteric capsules, BMS-986519

Recruiting Locations

Imaging Endpoints
Scottsdale 5313457, Arizona 5551752 85258
Contact:
Nida Laurin, Site 1619
480-290-1547

Nuovida Research Center
Miami 4164138, Florida 4155751 33186
Contact:
Jorge Betancourt, MD, Site 1604
786-616-9853

Epic Medical Research, LLC - Carrolton
Carrollton 4679195, Texas 4736286 75006
Contact:
Andrea Brown, Site 2616
972-782-2405

Pantheon Clinical Research, LLC
Bountiful 5771826, Utah 5549030 84010
Contact:
Jackson Rhudy, Site 2612
801-200-3950

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com