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临床试验/NCT01436188
NCT01436188已完成早期 1 期

A Biomarker Study to Measure CSF Proteins Upon Application of an Indwelling Lumbar Catheter for 36 Hours in Elderly Healthy Subjects and Subjects With Mild Cognitive Impairment or Alzheimer's Disease

Janssen Research & Development, LLC3 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
5
试验地点
3
主要终点
Measurement of CSF proteins

研究概览

简要总结

The purpose of this study is to investigate changes of cerebral spinal fluid (CSF) proteins over time using continuous CSF sampling for 36 hours in elderly healthy volunteers and volunteers with mild cognitive impairment or Alzheimer's Disease.

详细描述

This is a study to measure specific proteins in the cerebral spinal fluid (CSF) of healthy elderly volunteers and volunteers with mild cognitive impairment (MCI) or Alzheimer's Disease (AD). No investigational medical drug will be given to volunteers during their participation in this study. Healthy elderly volunteers will be enrolled in Part A of the study and will be randomized (assigned by chance) to 1 of 4 cohorts (groups); each cohort of volunteers will undergo a different type of CSF sampling procedure (a standard frequent CSF sampling procedure, an alternative frequency of CSF sampling procedure, or the standard frequent CSF sampling procedure with 800 mg ibuprofen administered to volunteers on Day 1, or an alternative lower frequency of CSF sampling in comparison to Cohort 1) and will have blood samples collected. Volunteers with MCI or AD will be enrolled in Part B of the study and will undergo 1 CSF sampling procedure (ie, the standard frequent CSF sampling procedure). In addition, all volunteers enrolled who consent (agree) to the pharmacogenomic component of the study, will have a blood sample collected that will allow for genetic research to help understand the link between Alzheimer's Disease biomarker profiles and specific genotypes and to have their DNA samples stored for future genetic research related to CSF proteins and Alzheimer's Disease. Participation in the pharmacogenomic research is optional for volunteers enrolled in Part A Cohort 1 to 3 but required for volunteers enrolled in Part A Cohort 5 and Part B. Participation in the DNA storage component is optional and refusal to participate will not result in ineligibility for the main part of the study. There will be no blinding in this study (ie, volunteers will know the CSF sampling procedure being performed on them). CSF and blood samples will be collected over a period of 36 hours and the maximum duration of the study will be no more than 6 weeks. During the study, volunteers will be monitored to evaluate the safety and tolerability of the CSF sampling procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

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

  • Healthy elderly Volunteers (Part A: age range 55 to 85 years of age, inclusive) and Volunteers with AD or MCI and a typical AD biomarker signature (Part B: age range 50 to 90 years of age, inclusive), with a body mass index (BMI) between 18 and 35 kg/m2 (inclusive) who satisfy the additional inclusion criteria specified in the study protocol will be eligible for enrollment in this study

排除标准

  • Has a clinically significant abnormal physical or neurological examination (including fundoscopy), vital signs or 12-lead electrocardiogram (ECG) at screening
  • Has a relevant history of lower back pain or scoliosis and/or major (lumbar) back surgery (microdiscectomy is allowed)
  • Has a history of spontaneous, prolonged or severe bleeding with unclear origin
  • Has a history of epilepsy or fits or unexplained black-out
  • has any other exclusion criteria as specified in the study protocol

研究组 & 干预措施

001 (Healthy Elderly Cohort 1)

Other

standard frequent CSF sampling procedure for 36 hours

干预措施: Standard CSR sampling procedure (Procedure)

002 (Healthy Elderly Cohort 2)

Other

an alternative frequency of CSF sampling procedure for 36 hours

干预措施: Alternate frequency CSR sampling procedure (Procedure)

003 (Healthy Elderly Cohort 3)

Other

standard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1

干预措施: Standard frequent CSR sampling procedure with 800 mg ibuprofen (Procedure)

004 (Elderly Volunteers with MCI or AD)

Other

standard CSF sampling procedure for 36 hours

干预措施: Standard CSR sampling procedure (Procedure)

005 (Healthy Eldely Cohort 5)

Other

an alternative lower frequency of CSF sampling in comparison to Cohort 1

干预措施: Alternative lower frequency CSR sampling procedure (Procedure)

结局指标

主要结局

Measurement of CSF proteins

时间窗: 36 hours

The changes in CSF proteins over 36 hours after lumbar introduction of a spinal catheter will be investigated.

次要结局

  • The number of volunteers with adverse events(Up to 6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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