An interventional study of testing, evaluation, sampling in Parkinson Disease and REM Sleep Behavior Disorder, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 80 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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iRBD group:
PD group:
Control group:
Exclusion Criteria:
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.
Other: testing, evaluation, sampling
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.
Other: testing, evaluation, sampling
Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only.
Other: testing, 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.
Frequency of development of Lewy body diseases
idiopathic RBD group only
Time frame: up to 4-years follow-up
Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)
descriptive, intragroup analysis
Time frame: 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
descriptive, intragroup analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Functional network changes predicted by [18F]FDG PET
descriptive, intragroup analysis
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Plan to share: Undecided
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital