Parkinson Disease, REM Sleep Behavior Disorder
Conditions
Keywords
Lewy body disease, REM Sleep Behavior Disorder, Parkinson disease, Imaging, Bio-markers, Prospective cohort
Brief summary
This is a prospective cohort study to evaluate degenerative changes in the brain by performing functional imaging analysis in patients with RBD and its correlations with clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes with functional imaging measures and olfactory and other premotor symptoms of Lewy body disease. This study also collects gene extracts and sera to develop a biomarker for early detection of neurodegeneration.
Detailed description
This study will include 3 groups in relation with RBD: idiopathic RBD (iRBD), PD- RBD, normal controls without RBD. In all groups, neurological examinations, olfactory testings, nonmotor symptoms evaluations, neuropsychological evaluations (detailed outcomes are in the outcome section) will be performed at baseline evaluation after enrollment. Image data will be obtained on following modalities: brain magnetic resonance imaging (MRI), 18F-N-ω-fluoropropyl- 2β-carbomethoxy- 3β-(4-iodophenyl) nortropane (\[18F\]FP-CIT) positron emission tomography (PET), and 18F-fludeoxyglucose(\[18F\]FDG) PET. To assess progression toward Lewy body disorders, patients in iRBD group will be evaluated at 2, and 4 years of follow-up visit. Clinical, neuropsychological tests, brain MRI, and two PET scans will be administered. After 4 years, patients who are willing to participate will be additionally followed-up yearly as a routine clinical visit with clinical and neurological examinations until obvious signs of Lewy body diseases will develop. In PD-RBD group, patients will be evaluated at 3-year follow-up period amongst days of routine clinic visits with administering clinical and neuropsychological tests.
Interventions
OTHERtesting, evaluation, sampling
neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.
Sponsors
SMG-SNU Boramae Medical Center
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
iRBD group: * A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria * No current neurological diseases related with RBD * Male or female aged from 30 to 80 years old at screening * Subject enrolled voluntarily and understood the contents of the study PD group: * A diagnosis of PD according to the UK Brain Bank Diagnostic Criteria * A diagnosis of RBD according to the international classification of sleep disorders-2 (ICSD-2) criteria * Male or female aged from 30 to 80 years old at screening * Subject enrolled voluntarily and understood the contents of the study Control group: * No current neurological or psychiatric diseases related with RBD * Male or female aged from 30 to 80 years old at screening * Age and sex matched with those of subjects in iRBD group * Subject enrolled voluntarily and understood the contents of the study
Exclusion criteria
* Clinically significant cognitive decline unable to follow the study (Mini-mental state examination \[MMSE\] score less than 20) * History of psychiatric illnesses (ex. depression) * Unable to walk and cooperate to the examination * Unable to take magnetic resonance imaging or positron emission tomography * Existence of illness or problems which makes difficult to be enrolled to the study judged by clinicians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of development of Lewy body diseases | up to 4-years follow-up | idiopathic RBD group only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS | from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) | descriptive, intragroup analysis |
| Cognitive change measured by the neuropsychological test battery | from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) | descriptive, intragroup analysis |
| Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry) | from baseline to 2-years and 4-years follow-up (iRBD group only) | descriptive, intragroup analysis |
| Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS) | from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) | descriptive, intragroup analysis |
| Degenerative brain changes predicted by [18F]FP-CIT PET | from baseline to 2-years and 4-years follow-up (iRBD group only) | descriptive, intragroup analysis |
| Functional network changes predicted by [18F]FDG PET | from baseline to 2-years and 4-years follow-up (iRBD group only) | descriptive, intragroup analysis |
| Functional network changes predicted by the resting-state functional MRI | from baseline to 2-years and 4-years follow-up (iRBD group only) | descriptive, intragroup analysis |
Countries
South Korea
Outcome results
None listed