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临床试验/NCT02686554
NCT02686554Unknown不适用

Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Cognitive Performance

研究概览

简要总结

At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to what extent the disease will devastate cognitive abilities within the next years. This is not only unsatisfying for the patient and the attending physician but also a major problem in the context of clinical trials that aim to establish new therapeutic agents. In clinical trials it is critically important to foresee as precisely as possible the course of the disease. The overall aim of the subproject is to identify a panel of CSF biomarkers to further improve specificity of diagnosis ("disease markers"), to measure disease activity and to predict AD progression ("stage and progression markers").

详细描述

Within the last years, protein analyses of Aβ-species in the cerebrospinal fluid (CSF) and amyloid-imaging using F18-based PET-tracers have become a part of the diagnostic repertoire in specialized memory clinics allowing a neurobiological, biomarker-based validation of Alzheimer´s disease (AD) diagnosis. This has led to a substantial increase in the specificity of the diagnostic procedure. However, the problem remains that the diverse factors, which influence disease progression are largely unknown, while tools for diagnosis have improved substantially.

We will identify patients for participation in a long-term clinical follow up study. Biomaterial (CSF, blood) will be obtained at baseline and subjected to a detailed protein analysis. In a subset of patients, a lumbar puncture will be repeated to compare baseline and follow up CSF. Within this study, a panel of proteins, comprising Aβ- and Tau-species as well as inflammation, glial and synaptic markers, potentially involved in disease progression will be measured in biomaterial from baseline and from follow up assessment. Clinical data will be correlated with the panel of disease and progression markers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Alzheimer´s Disease

排除标准

  • Other neurological or psychiatric diseases Stroke

结局指标

主要结局

Cognitive Performance

时间窗: 3-5 years

performance in the ADAS cog test battery

次要结局

  • Biomarker(3-5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Peters, MD

MD, senior resident

Charite University, Berlin, Germany

研究点 (1)

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