jRCT2031240393招募中不适用
A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 50age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Mild cognitive impairment (MCI) due to AD or mild AD dementia
- •Mini Mental State Examination (MMSE) score >=22 at Screening and Baseline and less than or equal to (<=) 30 at Screening and Baseline
- •Able to have CSF lumbar puncture performed and not on any anticoagulant therapy
- •Have an identified study partner
- •Provide written informed consent and willing and able to comply with all aspects of the protocol
排除标准
- •Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
- •Any psychiatric diagnosis or symptoms that could interfere with study procedures in the participants
- •Contraindications to MRI scanning. Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD, or other significant pathological findings
- •A clinically significant ECG abnormality
- •Participants with a bleeding disorder that is not under adequate control
- •Have thyroid-stimulating hormone above normal range or abnormally low serum vitamin B12 levels
- •Any suicidal ideation with intent with or without a plan at Screening, Baseline, or within 6 months of Screening (that is, answering ""Yes"" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS]) Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening)
- •Evidence of clinically significant disease that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments
- •Any immunological disease, that is not adequately controlled
- •Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
- •Known to be human immunodeficiency virus positive
- •Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately
研究者
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