Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Seoul National University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease REM Sleep Behavior Disorder

Interventions

testing, evaluation, samplingOTHER

neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological \& neurocognitive status by using a predefined neuropsychological assessment battery.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Frequency of development of Lewy body diseases

idiopathic RBD group only

Time frame: up to 4-years follow-up

Secondary Outcomes

Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)