2025-520746-30-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)
Bristol-Myers Squibb Services Unlimited Company40 个研究点 分布在 8 个国家目标入组 225 人开始时间: 2025年10月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 40
- 主要终点
- Change from baseline in ADAS-Cog11 at Week 24
研究概览
简要总结
To see if people with mild to moderate AD taking KarXT+KarX-EC improve in their thinking skills and global functioning (cognitive impairment and global functioning impairment).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females aged between 60 and 85 years.
- •Participants must have an MMSE score ranging from 12 through 22, inclusive, at the time of screening.
- •Participants are required to have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication and study procedure compliance, and assisting with medication administration.
- •Participants on AChEIs and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
排除标准
- •Participants with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment.
- •Participants with primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and to those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
- •Participants with a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
- •Participants with significant pathological findings on brain MRI at screening that could affect safety or interfere with study procedures.
结局指标
主要结局
Change from baseline in ADAS-Cog11 at Week 24
Change from baseline in ADAS-Cog11 at Week 24
CIBIC+ at Week 24
CIBIC+ at Week 24
次要结局
- Change from baseline in ADCS-ADL at Week 24
- Change from baseline in NPI total score at Week 24
- Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24
- Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24
研究者
GSM-CT Representative
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (40)
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