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Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

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ClinicalTrials.gov Identifier: NCT02984137
Recruitment Status : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jee-Young Lee, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease REM Sleep Behavior Disorder Other: testing, evaluation, sampling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
Actual Study Start Date : June 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: idiopathic RBD group
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
neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.

Active Comparator: incident PD group
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
neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.

Placebo Comparator: Control
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.




Primary Outcome Measures :
  1. Frequency of development of Lewy body diseases [ Time Frame: up to 4-years follow-up ]
    idiopathic RBD group only


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984137


Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jee-Young Lee, MD, PhD SMG-SNU Boramae Medical Center

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Responsible Party: Jee-Young Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02984137     History of Changes
Other Study ID Numbers: 16-2013-101
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jee-Young Lee, Seoul National University Hospital:
Lewy body disease
REM Sleep Behavior Disorder
Parkinson disease
Imaging
Bio-markers
Prospective cohort
Additional relevant MeSH terms:
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Parkinson Disease
REM Sleep Behavior Disorder
Disease
Mental Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders