CTRI/2026/02/0104945尚未招募3 期
A Phase 3, Open label Extension Study to Evaluate the Long term Safety and Tolerability of KarXT and KarX EC for the Treatment of Agitation Associated with Alzheimer Disease (ADAGIO 3)
Bristol Myers Squibb India Private Limited7 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年7月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Incidence of any TEAEs
研究概览
简要总结
The primary objective of this OLEstudy isto evaluate thelong-termsafety and tolerability of
KarXT+ KarX-EC in the treatment of participants with agitation associated with AD.
Study Duration: maximum duration after screening for each participant will be 30 weeks.
Study Intervention Duration - The study includes up to a 26-weekopen-label treatment period and
a SFU visit 4 weeks following the EOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 55.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply.
- •Participants must have completed study CN0120023 or CN0120024per protocol. Signed Written Informed Consent 2)Participants (or their LAR, see APPENDIX 1) must have signed and dated an IRB or IEC-approved 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, 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 participants 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.
排除标准
- •Participants are excludedfrom 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.
- •All grades of hepatic impairment (mild [Child-Pugh Class A), moderate(Child-Pugh Class B), and severe (Child-Pugh Class C)).
- •If, in the opinion of the Investigator and or Sponsor OR Medical Monitor, participant is unsuitable for enrollment in the study or participant has any finding that, in the view of the Investigator and OR or Sponsor OR Medical Monitor, may compromise the safety of the participant or affect his or her ability to adhere to the protocol visit schedule or fulfill visit requirements.
- •Risk of suicidal behavior during the study as determined by the Investigators clinical assessment and OR or C-SSRS as confirmed by the following: i)Answers Yes on items 3, 4, or 5 (C-SSRS –ideation) with the most recent episode occurring within the 2 months before screening or, ii)Answers Yes to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before Screening Physical and Laboratory Test Findings 5)An eGFR of less than or equal to 50mL per min at screening.
- •Elevations in hepatic transaminases at screening greater than or equal to 2× ULN for ALT and AST 7)Bilirubin greater than 2× ULN, unless in the context of Gilberts syndrome.
- •History of unstable hypertension or tachycardia as evidenced by- i)Blood pressure of greater than or equal to 160 or 100 mmHg (average of triplicate seated measures) at screening ii)Heart rate of greater than or equal to 100 bpm (average of triplicate seated measures) at screening 9)Urine toxicology screen positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator) 10)Clinically significant abnormal finding on the physical examination, medical history, ECG (QTcF of greater than 450 msec in males and greater than 470 msec in females), or clinical laboratory results at Screening.
结局指标
主要结局
Incidence of any TEAEs
时间窗: 26 weeks
次要结局
- Body weight and BMI(26 weeks)
- Reported AEs, TEAEs, SAEs, TEAEs leading to study(withdrawal and deaths)
- AESI(26 weeks)
- BARS and AIMS(26 weeks)
- Orthostatic vital signs (supine and standing OR sitting(and standing after 2 minutes): blood pressure (systolic)
- Clinical laboratory evaluations(26 weeks)
- 12-lead ECG(26 weeks)
- Suicidal ideation assessed using the C-SSRS(26 weeks)
- Assessment of cognition as measured by MMSE and(ADAS-Cog-13)
- Assessment of severity of benign prostatic hyperplasia(as measured by IPSS in male participant)
- Mean change from baseline to the end of Week 26 of EOT(on -)
- Change from baseline for biomarkers of(neurodegeneration and neuroinflammation over the)
研究者
Shilpi Sinha
Bristol Myers Squibb
研究点 (7)
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