The main objective of this study is to detect potential biomarkers for the differentiation of PD and DLB and the differentiation of PD subtypes by using neuroimaging.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of this study will include magnetic resonance imaging
(MRI) parameters, and clinical measures. Clinical data include important
demographic and disease-related characteristics as well as measures for disease
severity, and the important motor (motor functioning and motor complications),
and non-motor domains (cognition, depression, psychotic symptoms, sleep
problems, and autonomic dysfunction). The combination of clinical scores will
allocate PD patients in one of the four subtypes. MRI will be carried out on a
3T scanner and will include volumetric, diffusion, and functional MRI
parameters.
Secondary outcome
Not applicable.
Background summary
In prevalent Parkinson*s disease (PD), subtypes can be identified by clinical
characteristics. Identification of PD subtypes may have important consequences
for both the development of tailored treatment strategies and research of
underlying mechanisms since homeogeneous patient groups contribute to a better
coherence between phenotype, pathophysiology and genotype. In early PD,
however, clinical characteristics are insufficient to identify subtypes. In
addition, in the early phase, it is difficult to distinguish dementia with Lewy
bodies (DLB) from PD. Early differentiation of DLB and PD and differentiation
of clinical subtypes of PD might be possible with the use of quantitative
biomarkers of clinical traits. An important step in the development of
biomarkers that are potentially useful in early PD and DLB, is the
identification of biomarkers in established clinical subtypes of prevalent PD
and in prevalent DLB patients. In this study, neuroimaging will be used to
identify quantitative biomarkers in prevalent PD subtypes and in prevalent DLB.
Study objective
The main objective of this study is to detect potential biomarkers for the
differentiation of PD and DLB and the differentiation of PD subtypes by using
neuroimaging.
Study design
The proposed study will be a cross-sectional cohort and case-control study.
Study burden and risks
PD and DLB are progressive disorders with an unknown cause, with only
symptomatic treatment options. This study asks some effort from the patients
and is not directly helping the individual, but will provide more insight in
the pathophysiology of PD and DLB. The duration of all measurements may lead to
fatigue in some patients; in such cases, rest periods will be offered. If
patients develop more severe symptoms due to the measurements as performed in
the study, the study will be adapted to the person*s wishes, or will be ended.
If necessary, the neurologist on duty will be consulted.
Anatomical scans will be examined by a physician for unexpected findings. In
case of an unexpected finding a neurologist will be consulted and the case will
be discussed. If necessary, the participant*s general practitioner (GP) will be
contacted within 3 weeks after the scan. The participant will receive notice
that the GP was contacted; the GP will inform the participant about the
findings.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
For all participants a minimum age of 18 years is required.
All PD patients must fulfill the United Kingdom Parkinson*s Disease Society Brain Bank criteria for idiopathic PD. Patients with Lewy body dementie (DLB) must fulfill the McKeith DLB criteria and all patients must be diagnosed with PD or DLB by a movement disorder specialist.
Only patients who are mental competent are included.
Exclusion criteria
Participants with a contraindication for MRI are excluded.
Patients who underwent stereotactic surgery were excluded.
Controls with a disease of the central nervous system are excluded.
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 | NL34590.058.10 |