Clinical trial NCT02984137: Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder
Official title: A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
REM Sleep Behavior Disorder
Keywords: Lewy body disease
REM Sleep Behavior Disorder
Parkinson disease
Imaging
Bio-markers
Prospective cohort
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2016-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Frequency of development of Lewy body diseases
timeFrame: up to 4-years follow-up
Secondary outcomes:
measure: Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
measure: Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
measure: Cognitive change measured by the neuropsychological test battery
timeFrame: from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
measure: Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group only)
measure: Functional network changes predicted by the resting-state functional MRI
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group only)
measure: Degenerative brain changes predicted by [18F]FP-CIT PET
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group only)
measure: Functional network changes predicted by [18F]FDG PET
timeFrame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jee-Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: