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A Study to Measure CSF Proteins in Elderly Healthy Volunteers and Volunteers With Mild Cognitive Impairment or Alzheimer's Disease

NCT01436188 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Healthy
  • Alzheimer Disease

Interventions

PROCEDURE

Standard CSR sampling procedure

standard frequent CSF sampling procedure for 36 hours

PROCEDURE

Alternate frequency CSR sampling procedure

an alternative frequency of CSF sampling procedure for 36 hours

PROCEDURE

Standard frequent CSR sampling procedure with 800 mg ibuprofen

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

PROCEDURE

Standard CSR sampling procedure

standard frequent CSF sampling procedure for 36 hours.

PROCEDURE

Alternative lower frequency CSR sampling procedure

an alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Completion
2013-06-30

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436188 on ClinicalTrials.gov