NCT01436188

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 cognitive impairment or Alzheimer's Disease.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started Sep 2011

Typical duration for early_phase_1 healthy

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

First QC Date

September 15, 2011

Last Update Submit

March 15, 2014

Conditions

HealthyAlzheimer Disease

Keywords

Biological MarkersHealthy VolunteerAlzheimer's Disease (AD)Mild Cognitive Impairment (MCI)Cerebrospinal fluid (CSF)CSF proteins

Outcome Measures

Primary Outcomes (1)

  • Measurement of CSF proteins

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

    36 hours

Secondary Outcomes (1)

  • The number of volunteers with adverse events

    Up to 6 weeks

Study Arms (5)

001 (Healthy Elderly Cohort 1)

OTHER

standard frequent CSF sampling procedure for 36 hours

Procedure: Standard CSR sampling procedure

002 (Healthy Elderly Cohort 2)

OTHER

an alternative frequency of CSF sampling procedure for 36 hours

Procedure: Alternate frequency CSR sampling 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

Procedure: Standard frequent CSR sampling procedure with 800 mg ibuprofen

004 (Elderly Volunteers with MCI or AD)

OTHER

standard CSF sampling procedure for 36 hours

Procedure: Standard CSR sampling procedure

005 (Healthy Eldely Cohort 5)

OTHER

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

Procedure: Alternative lower frequency CSR sampling procedure

Interventions

Standard CSR sampling procedurePROCEDURE

standard frequent CSF sampling procedure for 36 hours

001 (Healthy Elderly Cohort 1)
Alternate frequency CSR sampling procedurePROCEDURE

an alternative frequency of CSF sampling procedure for 36 hours

002 (Healthy Elderly Cohort 2)
Standard frequent CSR sampling procedure with 800 mg ibuprofenPROCEDURE

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

003 (Healthy Elderly Cohort 3)
Alternative lower frequency CSR sampling procedurePROCEDURE

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

005 (Healthy Eldely Cohort 5)

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Leiden, Netherlands

Location

Related Publications (1)

  • Van Broeck B, Timmers M, Ramael S, Bogert J, Shaw LM, Mercken M, Slemmon J, Van Nueten L, Engelborghs S, Streffer JR. Impact of frequent cerebrospinal fluid sampling on Abeta levels: systematic approach to elucidate influencing factors. Alzheimers Res Ther. 2016 May 19;8(1):21. doi: 10.1186/s13195-016-0184-z.

    PMID: 27206648DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Janssen Research & Development, LLC C. Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 19, 2011

Study Start

September 1, 2011

Study Completion

June 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

BE(1)NL(2)