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

NCT ID
NCT06937229
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Conditions
Agitation, Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Enrollment: 650 participants (Estimated).

What is being studied

  • Drug: KarX-EC
  • Drug: KarXT
  • Intervention: xanomeline

Who may be eligible

Ages
55 Years to 90 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Participants must have completed study CN012-0023 or CN012-0024 per protocol. * Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week). 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 locations

252 study locations are listed.

Recruiting site status is explicitly provided for 252 locations; 49 are listed as Recruiting.

Countries: Argentina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States

  • Buenos Aires, Argentina: 3
  • Buenos Aires F.D., Argentina: 1
  • Santa Fe Province, Argentina: 1
  • Federal District, Brazil: 1
  • Paraná, Brazil: 2
  • Rio Grande do Sul, Brazil: 2
  • São Paulo, Brazil: 1
  • Ontario, Canada: 5
  • Santiago Metropolitan, Chile: 3
  • Valparaiso, Chile: 1
  • Beijing Municipality, China: 3
  • Guangdong, China: 2
  • Guangzhou Province, China: 1
  • Hunan, China: 1
  • Jiangsu, China: 1
  • Tianjin Municipality, China: 1
  • Zhejiang, China: 2
  • City of Zagreb, Croatia: 1
  • Olomouc Region, Czechia: 1
  • Praha 6, Czechia: 1
  • Praha 8, Czechia: 1
  • South Moravian, Czechia: 1
  • Haute-Garonne, France: 1
  • Rhône, France: 1
  • Achaḯa, Greece: 1
  • Attica, Greece: 2
  • Attikí, Greece: 1
  • Bács-Kiskun county, Hungary: 1
  • Győr-Moson-Sopron, Hungary: 1
  • Heves County, Hungary: 1

Sample of listed locations

  • Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, 90560-032, Brazil — Recruiting
  • CPQuali Pesquisa Clínica — São Paulo, 01228-000, Brazil — Recruiting
  • Medical Center Sveti Naum EOOD — Sofia, 1113, Bulgaria — Recruiting
  • Ontario Shores Centre For Mental Health Sciences — Whitby, Ontario, L1N 5S9, Canada — Recruiting
  • Centre Hospitalier Universitaire Toulouse - Cité de la Santé — Toulouse, Haute-Garonne, 31000, France — Recruiting
  • Sanz MC, Laniado Hospital — Netanya, 4244916, Israel — Recruiting
  • Bayit Balev Ltd. — Rishon Le'Tzion, 7590653, Israel — Recruiting
  • Auxologico IRCCS - Auxologico San Luca — Milan, Lombardy, 20149, Italy — Recruiting
  • Hatano Kousei Hospital — Hadano, Kanagawa, 257-0003, Japan — Recruiting
  • Asakayama Hospital — Sakai, Osaka, 590-0018, Japan — Recruiting
  • National Hospital Organization Hizen Psychiatric Center — Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192, Japan — Recruiting
  • Rainbow and Sea Hospital — Karatsu-shi, Saga-ken, 847-0031, Japan — Recruiting
  • Nippon Medical School Hospital — Bunkyo-ku, Tokyo, 113-8603, Japan — Recruiting
  • Kuramitsu Hospital — Fukuoka, 819-0037, Japan — Recruiting
  • Okayama City General Medical Center Okayama City Hospital — Okayama, 700-8557, Japan — Recruiting
  • AVIX Investigacion Clinica — Monterrey, Nuevo León, 64623, Mexico — Recruiting
  • Neurociencias PRISMA A.C. — San Luis Potosí City, 78216, Mexico — Recruiting
  • RCMed Oddzial Sochaczew — Sochaczew, 96-500, Poland — Recruiting
  • Inha University Hospital — Incheon, Incheon Gwang'yeogsi, 22332, South Korea — Recruiting
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea — Recruiting
  • Gangnam Severance Hospital, Yonsei University Health System — Seoul, 06273, South Korea — Recruiting
  • The Catholic University of Korea, Yeouido St.Mary's Hospital — Seoul, 07345, South Korea — Recruiting
  • Oroitu CAE — Getxo, Bizkaia, 48993, Spain — Recruiting
  • Hospital Clinico San Carlos — Madrid, 28040, Spain — Recruiting
  • Hospital Clinico Universitario Virgen de La Victoria — Málaga, 29010, Spain — Recruiting

Study details

Start date
December 2, 2025
Primary completion date
June 22, 2029
Completion date
July 20, 2029
First posted
April 22, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06937229
Registry last updated
September 16, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06937229 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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