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临床试验/NCT01329536
NCT01329536已完成不适用

The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease Compared to Age- and Gender-Matched, Non-Agitated In-Patients With Late-Onset Alzheimer's Disease

Avera McKennan Hospital & University Health Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Apolipoprotein E4 Allele

研究概览

简要总结

The purpose of this clinical research study is to determine if a specific genetic allele is involved with the development of agitation in patients with late-onset Alzheimer's Disease (AD). The study will compare the results of genetic testing between two groups: individuals with late-onset AD who show signs of agitation and individuals with late-onset AD who do not show signs of agitation.

详细描述

Agitation and other behavioral disturbances are a main cause in the need for increasing levels of care for the patient with Alzheimer's disease (AD). And while the pathology of dementia has been studied in great detail, the etiology is considered multi-factorial. The hypothesis behind this clinical study is that the presence of the apo lipoprotein E4 (APO E4) allele will serve to predict which patients with late on-set AD are at greater risk to develop agitation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women who are at least 65 years of age
  • Meet the DSM-IV-TR criteria for late-onset Alzheimer's Disease (AD)

排除标准

  • Unable to provide informed consent or do not have a legally acceptable caregiver and/or representative present or available to enter into the informed consent process on the study subject's behalf
  • Diagnosis of a non-Alzheimer's type of dementia
  • Determined by the Principal Investigator (or his designee) that the study subject would be unsuitable for study participation

结局指标

主要结局

Apolipoprotein E4 Allele

时间窗: Single clinic visit (day 1)

This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample and a saliva sample will be collected. Genetic results from this one-time specimen collection will be evaluated and compared with results from participants in the other study group of age- and gender-matched patients. Outcomes will be measured comparatively.

次要结局

未报告次要终点

研究者

发起方
Avera McKennan Hospital & University Health Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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