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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01436188
First received: September 15, 2011
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Alzheimer Disease
Procedure: Standard CSR sampling procedure
Procedure: Alternate frequency CSR sampling procedure
Procedure: Standard frequent CSR sampling procedure with 800 mg ibuprofen
Procedure: Alternative lower frequency CSR sampling procedure
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Measurement of CSF proteins [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    The changes in CSF proteins over 36 hours after lumbar introduction of a spinal catheter will be investigated.


Secondary Outcome Measures:
  • The number of volunteers with adverse events [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    The number and type of adverse events reported will be monitored.


Enrollment: 5
Study Start Date: September 2011
Study Completion Date: June 2013
Arms Assigned Interventions
001 (Healthy Elderly Cohort 1)
standard frequent CSF sampling procedure for 36 hours
Procedure: Standard CSR sampling procedure
standard frequent CSF sampling procedure for 36 hours
002 (Healthy Elderly Cohort 2)
an alternative frequency of CSF sampling procedure for 36 hours
Procedure: Alternate frequency CSR sampling procedure
an alternative frequency of CSF sampling procedure for 36 hours
003 (Healthy Elderly Cohort 3)
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
standard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1
004 (Elderly Volunteers with MCI or AD)
standard CSF sampling procedure for 36 hours
Procedure: Standard CSR sampling procedure
standard frequent CSF sampling procedure for 36 hours.
005 (Healthy Eldely Cohort 5)
an alternative lower frequency of CSF sampling in comparison to Cohort 1
Procedure: Alternative lower frequency CSR sampling procedure
an alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours

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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436188

Locations
Belgium
Antwerp, Belgium
Netherlands
Groningen, Netherlands
Leiden, Netherlands
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01436188     History of Changes
Other Study ID Numbers: CR100658, NOCOMPOUNDEDI0001, 2011-003525-94
Study First Received: September 15, 2011
Last Updated: March 15, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Janssen Research & Development, LLC:
Biological Markers
Healthy Volunteer
Alzheimer's Disease (AD)
Mild Cognitive Impairment (MCI)
Cerebrospinal fluid (CSF)
CSF proteins

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014