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)

Last updated:
2026-07-18
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View trial details

Overview

Official protocol 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 (ADAGIO-1)

Intervention/treatment:
XANOMELINE-TROSPIUM (KARXT, BMS-986510) / XANOMELINE (BMS-986519)
Medical condition:
ALZHEIMER'S DISEASE
Protocol code:
CN0120023
Control number:
300450
Status:
Recruiting
Approved:
September 02, 2025
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT07011732
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
55 Years to 90 Years
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role
CONTACT
Phone:
855-907-3286
Name
First line of the email MUST contain NCT # and Site #.
Role
CONTACT
Sponsor
BRISTOL-MYERS SQUIBB CANADA

Locations

Ontario

Centre for Addiction & Mental Health
Toronto, Ontario, M6J 1H4
Recruiting
Name
Sanjeev Kumar, Site 1154
Role
CONTACT
Phone:
416-535-8501 x32589
Local Institution - 1153
Hamilton, Ontario, L8M 1W9
Not yet recruiting
Name
Site 1153
Role
CONTACT
Local Institution - 1755
London, Ontario, N6A 5W9
WITHDRAWN
Name
Site 1155
Role
CONTACT
London Health Sciences Centre-Victoria Campus
London, Ontario, N6A 5W9
Recruiting
Name
Tuoyo Awani, Site 1155
Role
CONTACT
Phone:
519-685-8500 x77024
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, L1N 5S9
Recruiting
Name
Amer Burhan, Site 1152
Role
CONTACT
Phone:
905-430-4055 x6268
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Recruiting
Name
Sandra Black, Site 1151
Role
CONTACT
Phone:
416-480-6100 x4551

Quebec

Local Institution - 1150
Montreal, Quebec, H4A 3T2
Not yet recruiting
Name
Site 1150
Role
CONTACT
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