臨床研究等提出・公開システム

Date of registration	Jan. 23, 2026
Last modified on	Jan. 23, 2026
Trial ID	jRCT2031250672

Scientific 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)
Public Title	Open-label Extension of KarXT + KarX-EC for Agitation in Alzheimer's Disease (CN0120025)

Contact for Scientific Queries	Name	Sepulveda Rosalinda
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Sepulveda Rosalinda
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 23, 2026
Target sample size		600
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Participants must have completed study CN0120023 or CN0120024 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.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Agitation Associated with Alzheimer's Disease
Intervention(s)		KarXT + KarX-EC Arm: Administered orally twice daily at the specified dosage on the designated days.
Primary Outcome(s)		Incidence of any TEAEs
Secondary Outcome(s)		Reported AEs, TEAEs, SAEs, and TEAEs leading to study withdrawal and deaths AESI BARS and AIMS Body weight and BMI Orthostatic vital signs: blood pressure and heart rate Clinical laboratory evaluations 12-lead ECG Suicidal ideation assessed using the C-SSRS Assessment of cognition as measured by MMSE and ADAS-Cog-13 Assessment of severity of benign prostatic hyperplasia as measured by IPSS in male participants

Primary Sponsor	Bristol-Myers Squibb

Name of Certified Review Board	Teikyo University Mizonokuchi Hospital Institutional Review Board
Address	5-1-1, Futako, Takatsu-ku, Kawasaki, Kanagawa
Telephone	+81-44-844-3361
E-Mail	mizockn@med.teikyo-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 14, 2025

Plan to share IPD	Yes
Plan description	BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Countries of Recruitment（Except Japan）	United States/Argentina/Brazil/Bulgaria/Canada/Chile/China/Croatia/Czechia/France/Germany/Greece/Hungary/India/Israel/Italy/Mexico/Poland/Portugal/Romania/South Korea/Spain/Taiwan/Ukraine/United Kingdom