跳至主要内容
临床试验/NCT03702907
NCT03702907招募中不适用

DC Longitudinal Study on Aging and Specimen Bank

Georgetown University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
CDR

研究概览

简要总结

The Georgetown University Memory Disorders Program, part of the Department of Neurology, is conducting pilot studies of the feasibility of various diagnostic tests for Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. Further, this study is assessing longitudinal changes in biological, lifestyle, and cognitive assessment collection.

The primary goal of this study is to examine the feasibility of biochemical assays, genetic testing, and cognitive and lifestyle assessments in the ante-mortem diagnosis of Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. This research involves genetic and cognitive status testing but the findings will not be shared with research subjects. This will be accomplished ex vivo using blood, and/or cerebrospinal fluid (CSF) specimens from patients with a diagnosis of probable Alzheimer's disease, mild cognitive impairment, or other neurodegenerative diseases and from normal controls.

详细描述

These studies will examine the feasibility of using various biochemical assays in blood, and/or cerebrospinal fluid, genetic testing, cognitive status assessments, and lifestyle questionnaires to aid in the ante-mortem diagnosis of Alzheimer's and other neurodegenerative diseases.

Subjects have 2 options for participation. They may solely participate in the main study or the main study and the longitudinal substudy. The main study includes a single visit at which demographic and medical information will be recorded, brief cognitive testing, and blood and/or cerebrospinal fluid (CSF)(optional) specimens will be collected for the research assays. Genetic testing will take place. No clinical laboratory testing will be done and no results will be communicated to subjects.

During the Longitudinal substudy, each subject will be asked to participate in ongoing longitudinal study visits at which demographic and medical information will be recorded, cognitive testing and lifestyle questionnaire collection will occur, and blood and/or cerebrospinal fluid (CSF) specimens will be collected for the research assays. I

If one is eligible and agrees to participate in the longitudinal sub-study, they will be asked to come into the clinic for an Initial Study Visit, and then return every year or every other year, depending on which group they fit into (Cognitively Normal (CN), Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), other neurodegenerative disease) for ongoing Follow-Up Clinic Visits.

CN participants will come into the clinic every other year, with telephone checks occurring on alternating years, until the study ends.

研究设计

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

入排标准

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

入选标准

  • •Age 45 and older.
  • •Subjects within the age range of 45-50 years old must have a first degree relative with a neurodegenerative disease.

排除标准

  • •Individuals under 45 years of age

结局指标

主要结局

CDR

时间窗: 9 years

Clinical Dementia Rating

次要结局

未报告次要终点

研究者

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

R. Scott Turner

Director

Georgetown University

研究点 (1)

Loading locations...

相似试验