NCT06976203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 2)
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
- 586
- 试验地点
- 126
- 主要终点
- Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
- •Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
- •Participants must 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 compliance, and consenting to their involvement in both their own and the participant's study-related activities.
- •Participants on acetyl choline esterase inhibitors (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 must not present 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, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of <50 mL/min), and unstable hypertension or tachycardia.
- •Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
- •Participants must not have 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 must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT + KarX-EC
Active Comparator
干预措施: KarX-EC (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
KarXT + KarX-EC
Active Comparator
干预措施: KarXT (Drug)
结局指标
主要结局
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
时间窗: At week 24
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
时间窗: At week 24
次要结局
- Change from baseline in neuro psychiatric inventory (NPI) total score(At week 24)
- Number of participants with AEs leading to study intervention discontinuation(At week 24)
- Number of participants with clinically significant changes in vital signs(At week 24)
- Number of participants with clinically significant changes in electrocardiogram (ECG) tests(At week 24)
- Number of participants with adverse events (AEs)(At week 24)
- Number of participants with adverse event of special interest (AESIs)(At week 24)
- Number of participants with AEs leading to death(At week 24)
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)(At week 24)
- Number of participants with AEs leading to study discontinuation(At week 24)
- Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests(At week 24)
- Number of participants with clinically significant changes in weight(At week 24)
- Number of participants with clinically significant changes in safety laboratory tests(At week 24)
- Number of participants with serious adverse events (SAEs)(At week 24)
研究者
研究点 (126)
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