EUCTR2017-001364-38-LT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH EARLY (PRODROMAL TO 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
- 1,016
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
- •- Age 50-90 years
- •- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
- •- Evidence of AD pathological process, as confirmed by cerebrospinal fluid or amyloid positron emission tomography scan
- •- Demonstrate abnormal memory function
- •- MMSE score between 22-30 (inclusive)
- •- Clinical Dementia Rating Global Score of 0.5 or 1.0
- •- Availability of a reliable study partner who accepts to participate in study procedure throughout the study duration
- •- If receiving symptomatic AD medication the dosing regimen must have been stable for 3 months prior to screening and until randomization
- •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 203
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 813
排除标准
- •- Any evidence of a condition other than AD that may affect cognition
- •- History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
- •- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- •- Unstable or clinically significant cardiovascular, kidney or liver disease
- •- At risk of suicide in the opinion of the investigator
- •- Alcohol or substance abuse in past 2 years
- •- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- •- Any contraindications to brain magnetic resonance imaging
- •- Uncontrolled hypertension
研究者
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