Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Parkinson Disease Clinical Trial

Official title:

A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984137
• Other study ID #: 16-2013-101
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2018

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Parkinson Disease
• REM Sleep Behavior Disorder

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of development of Lewy body diseases	idiopathic RBD group only	up to 4-years follow-up
Secondary	Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Secondary	Nonmotor symptoms profile change assessed by a combined evaluatin using the non-motor symptom scale and part I of the MDS-UPDRS	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Secondary	Cognitive change measured by the neuropsychological test battery	descriptive, intragroup analysis	from baseline to 2-years ad 4-years follow-up (iRBD group), to 3-years follow-up (PD-RBD group)
Secondary	Degenerative brain changes predicted by MRI (diffusion tensor analysis and volumetry)	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group only)
Secondary	Functional network changes predicted by the resting-state functional MRI	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group only)
Secondary	Degenerative brain changes predicted by [18F]FP-CIT PET	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group only)
Secondary	Functional network changes predicted by [18F]FDG PET	descriptive, intragroup analysis	from baseline to 2-years and 4-years follow-up (iRBD group only)