Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup-A Pilot Descriptive Study
研究概览
详细说明
The objective of this study is to apply AclarusDx™ signature in a reference US Center in 160 patients newly referred to one of the three study centers within the Cleveland Clinic, Center for Brain Health network, for diagnostic workup. Only AclarusDx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of AclarusDx™ to provide Primary Care Physicians (PCPs) with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).
The primary objectives are :
- To obtain an estimate of the capability of AclarusDx™ to identify AD patients among a US-based population of newly referred patients suffering from objective memory impairment which maybe potentially related to multiple and different etiologies.
- To compare the performance of AclarusDx™ in a US-based population of newly referred patients with memory impairment with the performance of AclarusDx™ observed in one comparable European population.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Nevada
-
Las Vegas、Nevada、美国、89106
- Cleveland Clinic Lou Ruvo Center for Brain Health
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic Center for Brain Health - Mellen Center
-
Lakewood、Ohio、美国、44107
- Cleveland Clinic Senior Care Assessment - Lakewood Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female patient referred to the center for memory impairment.
- The memory impairment has previously been observed by a caregiver or documented by a physician.
- The memory impairment is confirmed by the memory center.
- Caucasian ethnicity.
- A written informed consent approved by an ethical review board or similar body must be obtained from the patient prior to any study-related procedures.
- If applicable, standard treatment with cholinesterase inhibitor and/or memantine is acceptable.
- Patient estimated to be compliant with study procedures.
- Patient has a level of understanding sufficient to agree to all procedures required by the protocol and must be able to cooperate. Under no circumstances will a subject who does not understand the procedure, be allowed to consent to the procedure.
Exclusion Criteria:
- Recent acute pathology or medical condition or surgery which may alter the inflammatory homeostasis, according to the opinion of the investigator.
- Non-Caucasian ethnicity.
- Patient with severe uncontrolled or unstable medical condition.
- Need for a legal representative for the medical condition of the patient.
- Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
- Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions that are considered stable are accepted, provided that they are compatible with other study selection criteria.
- Current or recent history of drug or alcohol abuse or dependence.
- Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition text revised (DSM-IV TR), or significant symptoms (eg, hallucinations).
- Woman of childbearing potential is not allowed to participate in the study. (A woman of childbearing potential is a woman who is biologically capable of becoming pregnant).
- Current participation in another study using an investigational non-marketed product.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
Study patients
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sensitivity of AclarusDx™ in AD patients
大体时间:Outcome measured during one single study visit
|
The determination of the sensitivity of the test, being the percentage of positive AclarusDx™ calls among referred patients being confirmed clinically as having AD at the Memory Center will be calculated.
|
Outcome measured during one single study visit
|
合作者和调查者
赞助
调查人员
- 首席研究员:Charles B. Bernick, MD、Cleveland Clinic Lou Ruvo Center for Brain Health
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- EHTAD/003
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.