This study aims to show increased microglia activation in brain parts involved in PD pathology, comparing PD patients with age-matched healthy control subjects. To see whether microglia activation changes early in the course of Parkinson*s disease (…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Uptake of the radiolabeled PK11195 measured with PET as a measure of activated
microglia in neuroinflammation. The groups will be statistically compared using
an SPM programme.
Secondary outcome
not applicable
Background summary
The cause of Parkinson's disease is unknown. Neuroinflammation is suggested to
play a role in the progression of neurodegeneration. Neuroinflammation can be
measured in vivo in patients with PET and radiolabeled PK11195. Finding the
source pathogenic mechanisms triggering this neurodegenerative disease is
needed to develop effective neuroprotective intervention.
Study objective
This study aims to show increased microglia activation in brain parts involved
in PD pathology, comparing PD patients with age-matched healthy control
subjects.
To see whether microglia activation changes early in the course of Parkinson*s
disease (PD), de novo PD patients will be compared to patients in later stages
of the disease.
Study design
Prior to entering the PET study, subjects will undergo general medical and
neurological screening. If subjects fulfill the criteria for entering the
study, in a next visit they will undergo a [11C]-PK11195 PET scan and MRI scan
of the brain.
Images will be analysed and groups will be compared using a Statistical
Parametric Mapping (SPM) programme.
Study burden and risks
PET scan with radiolabeled PK11195 results in minimal radiation load. Bleeding
risk after blood sampling with the scan will be minimised by applying pressure
on site of sampling. Subjects are asked to be able to lay without moving their
head in the PET scanner during one hour.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria (healthy volunteers)
Age over 40
Informed consent;Inclusion criteria (patients)
-Age over 40
-Informed consent.
-Regarded by the treating physician to have competence of judgement.
-Compliance with the criteria for possible or probable PD as proposed by Gelb, Oliver and Gilman [1999]
-de novo PD without PD medication, or advanced PD with Hoehn and Yahr stage of at least 2.
Exclusion criteria
Exclusion criteria (all PET-study subjects)
- Prior cardiovascular brain disease, other brain disease (including former traumatic contusion)
- Evidence of any general medical disease, e.g. significant kidney or liver disease, evidence of autoimmune disease.
- Use of anti-inflammatory medication: NSAID*s and steroids.
- Use of benzodiazepines. Benzodiazepines have affinity for the PBR receptor that binds the PET tracer PK11195 and can interfere with the study.
- Abnormalities at clinical neurological examination
- Pregnancy in women of childbearing potential.
- Exposure to a significant amount of radiation in the past year.
- Radiological workers.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13492.042.06 |