Clinical Trial: Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder

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 Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Frequency of development of Lewy body diseases [ Time Frame: up to 4-years follow-up ]

idiopathic RBD group only


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS) [ Time Frame: from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group) ]
    descriptive, intragroup analysis
  • Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: from baseline to 2-years and 4-years follow-up (iRBD group only) ]
    descriptive, intragroup analysis
  • Degenerative brain changes predicted by [18F]FP-CIT PET [ Time Frame: from baseline to 2-years and 4-years follow-up (iRBD group only) ]
    descriptive, intragroup analysis
  • Functional network changes predicted by [18F]FDG PET [ Time Frame: from baseline to 2-years and 4-years follow-up (iRBD group only) ]
    descriptive, intragroup analysis


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: November 30, 2016
Date Started: September 2013
Date Completion: April 2019
Last Updated: February 21, 2017
Last Verified: February 2017