Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease REM Sleep Behavior Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

testing, evaluation, sampling

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

testing, evaluation, sampling

Intervention Type OTHER

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

Control

Control group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only.

Group Type PLACEBO_COMPARATOR

testing, evaluation, sampling

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes