Normal AgingPhase 1NCT00205595
Normal Binding of R-[11C]PK11195 in Human Subjects
A Phase 1 study testing Positron Emission Tomography in people with Normal Aging, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This is a study using Positron Emission Tomography (PET) to study the normal distribution of the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain in several brain disorders like Alzheimer's disease and traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Aging
- What is being tested?
- Positron Emission Tomography
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2001to Jan 2007
- Phase
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Good physical and mental Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
- Age between 18 and 40 years (20 subjects) and between 40 and 80 years (20 subjects).
- Mini Mental State score >27
- Body Mass Index (B.M.I.) between 20 -25.
- Written informed consent of the subject.
- Hb must be >8 mmol \ liter at the time of the screening.
Who cannot join
- Previous neurotrauma with loss of consciousness
- Any clinical significant abnormality of any clinical laboratory test, including drug screening, or ECG abnormality.
- History of hypertension
- Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.
- History of psychiatric or neurological illness
- History of psychiatric or neurological illness in first-degree relatives
Show all 11Show fewer
- History of alcohol and/or drug abuse (DSM-IV criteria)
- Current use of any medication
- Blood donation within 3 months before the scan day
- Claustrophobia
- Metal objects in or around the body (braces, pacemaker, metal fragments);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Distribution and Quantification of Specific Binding of the Positron Emission Tomography Tracer R)-[11C]PK11195 in Normal Human Subjects
This is a study using Positron Emission Tomography (PET) to study the normal distribution of the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain in several brain disorders like Alzheimer's disease and traumatic brain injury.
Read the detailed description
At the University Hospital Vrije Universiteit the PET ligand PK11195 labeled with carbon-11, (R)-[11C]PK11195, will be used to study microglia activation in-vivo in patients with traumatic brain damage, Alzheimer disease, multiple sclerosis and neuritis optica, disorders with unknown pathophysiology and treatment difficulties.
PK11195 (1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl)-3 isoquinolinecarboxamide) is a highly specific ligand for the peripheral benzodiazepine-binding site, which is particularly abundant on cells of the mononuclear macrophage line (Myers et al., 1991). In normal human brain, the peripheral-type benzodiazepine receptor ligand PK11195 exhibits low to minimal binding primarily associated with the choroid plexus, ependymal linings and glial cells. However, following neuronal damage, the cells involved in the ensuing gliosis, microglia, show a marked increase in expression of these sites (Stephenson et al., 1995;Conway et al., 1998).
PK11195 labeled with carbon-11 is a PET ligand to peripheral type benzodiazepine receptors which has already been used in patients with stroke (Ramsay et al., 1992), Rasmussen's encephalitis (Banati et al., 1999), multiple sclerosis (Banati et al., 1997) and facial nerve lesions (Myers et al., 1999). However, no tracer kinetic model for quantification has been fully validated for(R)-[11C]PK11195. In order to use (R)-[11C]PK11195 for PET-imaging of microglia activation and to use it in the longitudinal monitoring of disease progression, baseline levels of ligand uptake in a healthy control population are required. This study aims to measure (R)-[11C]PK11195 uptake in normal brain in different age groups and to develop methods for quantification of specific binding of (R)-[11C]PK11195. Because (R)-[11C]PK11195 uptake depends on regional bloodflow, each (R)-[11C]PK11195 scan will be preceded by a cerebral bloodflow scan with H215O.
OBJECTIVES
- Determine the distribution of (R)-[11C]PK11195 in normal brain
- Develop methods for quantification of specific binding of (R)-[11C]PK11195
- Determine the metabolic profile of (R)-[11C]PK11195 in healthy volunteers
DESIGN OF THE STUDY Forty healthy subjects will be recruited, 20 males and 20 females. This is an open study. The study consists of one PET scan, which will be performed at the Department of Nuclear Medicine \& PET research of the VU University Medical Centre.
- Conditions
- Normal Aging
- Being tested
- Positron Emission Tomography
- Keywords
- microglia, PET, PK11195
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
specific binding of tracer depending on age
Secondary outcomes (1)
tracer kinetic method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2001
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal AgingStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Investigators
- Bart van Berckel, MD; PhD, Principal investigator, VUmc Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205595
- Sponsor's protocol ID
- 2001/001
- Other IDs
- no other ID's
- Status last verified
- Jul 2008
- First submitted
- 12 Sep 2005
- Last updated
- 8 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distribution and Quantification of Specific Binding of the Positron Emission Tomography Tracer R)-[11C]PK11195 in Normal Human Subjects
- ClinicalTrials.gov ID
- NCT00205595
- Acronym / sponsor ID
- 2001/001
- Conditions
- Normal Aging
- Keywords
- microglia, PET, PK11195
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Feb 2001
- Study completion
- Jan 2007
- First posted
- 20 Sep 2005 (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.
This is a study using Positron Emission Tomography (PET) to study the normal distribution of the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain in several brain disorders like Alzheimer's disease and traumatic brain injury.
Detailed description
At the University Hospital Vrije Universiteit the PET ligand PK11195 labeled with carbon-11, (R)-[11C]PK11195, will be used to study microglia activation in-vivo in patients with traumatic brain damage, Alzheimer disease, multiple sclerosis and neuritis optica, disorders with unknown pathophysiology and treatment difficulties.
PK11195 (1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl)-3 isoquinolinecarboxamide) is a highly specific ligand for the peripheral benzodiazepine-binding site, which is particularly abundant on cells of the mononuclear macrophage line (Myers et al., 1991). In normal human brain, the peripheral-type benzodiazepine receptor ligand PK11195 exhibits low to minimal binding primarily associated with the choroid plexus, ependymal linings and glial cells. However, following neuronal damage, the cells involved in the ensuing gliosis, microglia, show a marked increase in expression of these sites (Stephenson et al., 1995;Conway et al., 1998).
PK11195 labeled with carbon-11 is a PET ligand to peripheral type benzodiazepine receptors which has already been used in patients with stroke (Ramsay et al., 1992), Rasmussen's encephalitis (Banati et al., 1999), multiple sclerosis (Banati et al., 1997) and facial nerve lesions (Myers et al., 1999). However, no tracer kinetic model for quantification has been fully validated for(R)-[11C]PK11195. In order to use (R)-[11C]PK11195 for PET-imaging of microglia activation and to use it in the longitudinal monitoring of disease progression, baseline levels of ligand uptake in a healthy control population are required. This study aims to measure (R)-[11C]PK11195 uptake in normal brain in different age groups and to develop methods for quantification of specific binding of (R)-[11C]PK11195. Because (R)-[11C]PK11195 uptake depends on regional bloodflow, each (R)-[11C]PK11195 scan will be preceded by a cerebral bloodflow scan with H215O.
OBJECTIVES
- Determine the distribution of (R)-[11C]PK11195 in normal brain
- Develop methods for quantification of specific binding of (R)-[11C]PK11195
- Determine the metabolic profile of (R)-[11C]PK11195 in healthy volunteers
DESIGN OF THE STUDY Forty healthy subjects will be recruited, 20 males and 20 females. This is an open study. The study consists of one PET scan, which will be performed at the Department of Nuclear Medicine \& PET research of the VU University Medical Centre.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects
- Good physical and mental Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
- Age between 18 and 40 years (20 subjects) and between 40 and 80 years (20 subjects).
- Mini Mental State score >27
- Body Mass Index (B.M.I.) between 20 -25.
Key exclusion criteria (11 listed)
- Previous neurotrauma with loss of consciousness
- Any clinical significant abnormality of any clinical laboratory test, including drug screening, or ECG abnormality.
- History of hypertension
- Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.
- History of psychiatric or neurological illness
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 |
|---|---|---|
| Positron Emission Tomography | Device | – |
Primary outcome
specific binding of tracer depending on age
1 secondary outcome
tracer kinetic method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
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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.
Bart van Berckel, MD; PhD principal investigator
VUmc Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Positron Emission Tomography in people with Normal Aging, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
specific binding of tracer depending on age. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2008.