Status:
COMPLETED
A Study to Measure CSF Proteins in Elderly Healthy Volunteers and Volunteers With Mild Cognitive Impairment or Alzheimer's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Alzheimer Disease
Eligibility:
All Genders
50-90 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
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 invest...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01436188
Start Date
September 1 2011
End Date
June 1 2013
Last Update
March 18 2014
Active Locations (3)
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1
Antwerp, Belgium
2
Groningen, Netherlands
3
Leiden, Netherlands