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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| idiopathic RBD group | Experimental | A group of patients diagnosed as idiopathic RBD that is confirmed by polysomnography. Interventions as testing, evaluation, samplings at baseline, then repeat at 2 years and 4 years of prospective follow-up. thereafter only clinical observations until Lewy body disease is diagnosed. |
|
| incident PD group | Active Comparator | A group of patients who are newly diagnosed as Parkinson's disease, and never been treated with prolonged history of probable RBD. Interventions as testing, evaluation, sampling at baseline and then evaluations only at 3 year follow-up after anti-parkinsonian treatment. |
|
| Control | Placebo Comparator | Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| testing, evaluation, sampling | Other | neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of development of Lewy body diseases | idiopathic RBD group only | up to 4-years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS) | descriptive, intragroup analysis | from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) |
| Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS |
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Inclusion Criteria:
iRBD group:
PD group:
Control group:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jee-Young Lee, MD, PhD | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020187 | REM Sleep Behavior Disorder |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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descriptive, intragroup analysis |
| from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) |
| Cognitive change measured by the neuropsychological test battery | descriptive, intragroup analysis | from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) |
| Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry) | descriptive, intragroup analysis | from baseline to 2-years and 4-years follow-up (iRBD group only) |
| Functional network changes predicted by the resting-state functional MRI | descriptive, intragroup analysis | from baseline to 2-years and 4-years follow-up (iRBD group only) |
| Degenerative brain changes predicted by [18F]FP-CIT PET | descriptive, intragroup analysis | from baseline to 2-years and 4-years follow-up (iRBD group only) |
| Functional network changes predicted by [18F]FDG PET | descriptive, intragroup analysis | from baseline to 2-years and 4-years follow-up (iRBD group only) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |