EUCTR2017-002901-37-DE进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects with Mild Cognitive Impairment due to Alzheimer’s Disease or with Mild Alzheimer’s Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 528
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Must have a gradual and progressive change in memory function over more than 6 months.
- •Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD and must have
- •o Objective evidence of cognitive impairment at Screening
- •o Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
- •o Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
- •o CDR Memory Box score of =0.5
- •Must consent to apolipoprotein E (ApoE) genotyping
- •Must have 1 informant/study partner
- •Must have amyloid beta positivity confirmed at Screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 232
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •Key Exclusion Criteria:
- •Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant’s cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
- •Clinically significant, unstable psychiatric illness
- •Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- •Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- •History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
- •Indication of impaired renal or liver function
- •Alcohol or substance abuse in past 1 year
- •Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
- •Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
- •Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant’s ability to perform cognitive testing or complete study procedures.
- •Contraindications to study procedures
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究者
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