跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT06937229
NCT06937229招募中3 期

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)

Bristol-Myers Squibb348 个研究点 分布在 8 个国家目标入组 650 人开始时间: 2025年12月2日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
650
试验地点
348
主要终点
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

研究组 & 干预措施

KarXT+KarX-EC

Experimental

干预措施: KarXT (Drug)

KarXT+KarX-EC

Experimental

干预措施: KarX-EC (Drug)

结局指标

主要结局

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

时间窗: Up to approximately Week 30

次要结局

  • Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)(Up to approximately Week 30)
  • Number of Participants With Clinically Significant Changes in Laboratory Evaluations(Up to approximately Week 30)
  • Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)(Up to approximately Week 26)
  • Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to approximately Week 30)
  • Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)(Up to approximately Week 26)
  • Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)(Up to approximately Week 26)
  • Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)(Up to approximately Week 26)
  • Number of Participants With Adverse Events (AEs)(Up to approximately Week 30)
  • Number of Participants With Serious AEs (SAEs)(Up to approximately Week 30)
  • Number of Participants With TEAEs Leading to Study Withdrawal(Up to approximately Week 30)
  • Number of Participants With TEAEs Leading to Death(Up to approximately Week 30)
  • Number of Participants with Adverse Events of Special Interest (AESI)(Up to approximately Week 30)
  • Change From Baseline in Barnes Akathisia Rating Scale (BARS)(Up to approximately Week 26)
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)(Up to approximately Week 26)
  • Change From Baseline in Body Weight(Up to approximately Week 26)
  • Change From Baseline in Body Mass Index (BMI)(Up to approximately Week 26)
  • Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)(Up to approximately Week 30)
  • Number of Participants With Adverse Events (AEs)(Up to approximately Week 30)
  • Number of Participants With Serious AEs (SAEs)(Up to approximately Week 30)
  • Number of Participants With TEAEs Leading to Study Withdrawal(Up to approximately Week 30)
  • Number of Participants With TEAEs Leading to Death(Up to approximately Week 30)
  • Number of Participants with Adverse Events of Special Interest (AESI)(Up to approximately Week 30)
  • Change From Baseline in Barnes Akathisia Rating Scale (BARS)(Up to approximately Week 26)
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)(Up to approximately Week 26)
  • Change From Baseline in Body Weight(Up to approximately Week 26)
  • Change From Baseline in Body Mass Index (BMI)(Up to approximately Week 26)
  • Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)(Up to approximately Week 30)
  • Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)(Up to approximately Week 30)
  • Number of Participants With Clinically Significant Changes in Laboratory Evaluations(Up to approximately Week 30)
  • Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)(Up to approximately Week 26)
  • Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to approximately Week 30)
  • Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)(Up to approximately Week 26)
  • Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)(Up to approximately Week 26)
  • Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)(Up to approximately Week 26)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (348)

Loading locations...

相似试验

已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JPRheumatoid Arthritis
NCT00144547Chugai Pharmaceutical241
已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JPRheumatoid Arthritis
NCT00144534Chugai Pharmaceutical115
已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JPRheumatoid Arthritis
NCT00144586Chugai Pharmaceutical42
已完成
3 期
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)Polyarticular Juvenile Idiopathic Arthritis
NCT00144625Chugai Pharmaceutical19
终止
3 期
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and BezafibratePrimary Biliary Cholangitis
NCT06488911Intercept Pharmaceuticals62