Clinical Trials List
2026-03-01 - 2029-12-31
Phase III
Recruiting5
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)
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/30
Investigators and Locations
Co-Principal Investigator
- Chen-Chung Liu 無
- 楊焯翔 無
- CHIH-MIN LIU 無
- 顏薇軒 無
- 鄭龍驊 無
- 謝明憲 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張維紘 無
- Wei-Pin Hong 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1) Participants must have completed study CN0120023 or CN0120024 per protocol.
Signed Written Informed Consent
2) Participants [or their LAR, see APPENDIX 1] must have signed and dated an IRB/IECapproved
written ICF in accordance with regulatory, local, and institutional guidelines. This
ICF must be obtained before performing any protocol-related procedures that are not part of
normal patient care. If the participant is deemed not competent to provide IC (as determined
by the investigator), the participant should provide informed assent, if required by local
regulations.
3) Have one identified caregiver who should have sufficient contact (approximately 10 hours a
week or more) and is willing to:
Attend all visits and report on participant’s status
Oversee participant compliance with medication and study procedures
Participate in the study assessments and provide IC to participate in the study
The caregiver role in non-institutionalized settings may or may not be the same individual
who fulfills the role of caretaker. In institutionalized settings (eg, nursing homes or
memory care facilities), a caregiver may be a staff member of the institutionalized setting
or another individual (eg, family member, family friend, hired professional caregiver) who
fulfills the above criteria.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1) History or presence (including those that could have developed during study CN0120023 or
CN0120024) of clinically significant cardiovascular (eg, untreated or unstable hypertension,
clinically significant tachycardia), pulmonary, renal, hematologic, GI, eg, obstructive
disorders (including conditions that may decrease GI motility, such as ulcerative colitis,
intestinal atony, and myasthenia gravis), 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.
2) All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class
B], and severe [Child-Pugh Class C]).
3) If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, participant is unsuitable
for enrollment in the study or participant has any finding that, in the view of the Investigator
and/or Sponsor/Medical Monitor, may compromise the safety of the participant or affect
his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
600 participants
