Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

NCT02984137 | Completed DMC

• 1 other identifier: 16-2013-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Keywords

Lewy body disease; REM Sleep Behavior Disorder; Parkinson disease; Imaging; Bio-markers; Prospective cohort

Outcome Measures

Primary Outcomes (1)

• Frequency of development of Lewy body diseases

  idiopathic RBD group only

  up to 4-years follow-up

Secondary Outcomes (7)

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

  from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

• Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS

  from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

• Cognitive change measured by the neuropsychological test battery

  from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)

• Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)

  from baseline to 2-years and 4-years follow-up (iRBD group only)

• Functional network changes predicted by the resting-state functional MRI

  from baseline to 2-years and 4-years follow-up (iRBD group only)

Study Arms (3)

idiopathic RBD group

EXPERIMENTAL

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

incident PD group

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Other: testing, evaluation, sampling

Interventions

testing, evaluation, sampling 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; idiopathic RBD group; incident PD group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Dementia; Neurocognitive Disorders

Study Officials

• Jee-Young Lee, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 6, 2016
• Study Start: June 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

KR (1)