HealthyEarly Phase 1NCT01436188
A Study to Measure CSF Proteins in Elderly Healthy Volunteers and Volunteers With Mild Cognitive Impairment or Alzheimer's Disease
A Early Phase 1 study testing Standard CSR sampling procedure, Alternate frequency CSR sampling procedure and Standard frequent CSR sampling procedure with 800 mg ibuprofen in people with Healthy and Alzheimer Disease, run by Janssen Research & Development, LLC at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alzheimer Disease
- What is being tested?
- Standard CSR sampling procedure, Alternate frequency CSR sampling procedure and Standard frequent CSR sampling procedure with 800 mg ibuprofen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2011to Jun 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Alzheimer Disease
- Being tested
- Standard CSR sampling procedure, Alternate frequency CSR sampling procedure, Standard frequent CSR sampling procedure with 800 mg ibuprofen, Alternative lower frequency CSR sampling procedure
- Keywords
- Biological Markers, Healthy Volunteer, Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI), Cerebrospinal fluid (CSF), CSF proteins
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CSR sampling procedureProcedure or surgery
standard frequent CSF sampling procedure for 36 hours
Alternate frequency CSR sampling procedureProcedure or surgery
an alternative frequency of CSF sampling procedure for 36 hours
Standard frequent CSR sampling procedure with 800 mg ibuprofenProcedure or surgery
standard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1
Standard CSR sampling procedureProcedure or surgery
standard frequent CSF sampling procedure for 36 hours.
Alternative lower frequency CSR sampling procedureProcedure or surgery
an alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours
| Study group | Role | What they receive |
|---|---|---|
| 001 (Healthy Elderly Cohort 1) | Other | standard frequent CSF sampling procedure for 36 hours Receives: Procedure: Standard CSR sampling procedure |
| 002 (Healthy Elderly Cohort 2) | Other | an alternative frequency of CSF sampling procedure for 36 hours Receives: 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 Receives: 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 Receives: Procedure: Standard CSR sampling procedure |
| 005 (Healthy Eldely Cohort 5) | Other | an alternative lower frequency of CSF sampling in comparison to Cohort 1 Receives: Procedure: Alternative lower frequency CSR sampling procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of CSF proteins
The changes in CSF proteins over 36 hours after lumbar introduction of a spinal catheter will be investigated.
Measured: 36 hours
Secondary outcomes (1)
The number of volunteers with adverse events
The number and type of adverse events reported will be monitored.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436188
- Sponsor's protocol ID
- CR100658
- Other IDs
- NOCOMPOUNDEDI0001, 2011-003525-94
- Status last verified
- Mar 2014
- First submitted
- 15 Sep 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
Publications
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.
PubMed 27206648
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01436188
- Acronym / sponsor ID
- CR100658
- Conditions
- Healthy, Alzheimer Disease
- Keywords
- Biological Markers, Healthy Volunteer, Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI), Cerebrospinal fluid (CSF), CSF proteins
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 001 (Healthy Elderly Cohort 1) | Other | Procedure: Standard CSR sampling procedurestandard frequent CSF sampling procedure for 36 hours |
| 002 (Healthy Elderly Cohort 2) | Other | Procedure: Alternate frequency CSR sampling procedurean alternative frequency of CSF sampling procedure for 36 hours |
| 003 (Healthy Elderly Cohort 3) | Other | Procedure: Standard frequent CSR sampling procedure with 800 mg ibuprofenstandard 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) | Other | Procedure: Standard CSR sampling procedurestandard CSF sampling procedure for 36 hours |
| 005 (Healthy Eldely Cohort 5) | Other | Procedure: Alternative lower frequency CSR sampling procedurean alternative lower frequency of CSF sampling in comparison to Cohort 1 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CSR sampling procedurestandard frequent CSF sampling procedure for 36 hours | Procedure or surgery | 001 (Healthy Elderly Cohort 1) |
| Alternate frequency CSR sampling procedurean alternative frequency of CSF sampling procedure for 36 hours | Procedure or surgery | 002 (Healthy Elderly Cohort 2) |
| Standard frequent CSR sampling procedure with 800 mg ibuprofenstandard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1 | Procedure or surgery | 003 (Healthy Elderly Cohort 3) |
| Standard CSR sampling procedurestandard frequent CSF sampling procedure for 36 hours. | Procedure or surgery | 004 (Elderly Volunteers with MCI or AD) |
| Alternative lower frequency CSR sampling procedurean alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours | Procedure or surgery | 005 (Healthy Eldely Cohort 5) |
Primary outcome
Measurement of CSF proteins
Time frame: 36 hours
The changes in CSF proteins over 36 hours after lumbar introduction of a spinal catheter will be investigated.
1 secondary outcome
The number of volunteers with adverse events
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Derived from this study: PubMed 27206648Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC C. Clinical Trial study director
Janssen Research & Development, LLC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard CSR sampling procedure, Alternate frequency CSR sampling procedure and Standard frequent CSR sampling procedure with 800 mg ibuprofen in people with Healthy and Alzheimer Disease, run by Janssen Research & Development, LLC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of CSF proteins (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01436188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014; AzTrials last refreshed its copy on 6 Nov 2026.