Parkinson DiseaseNCT02984137
Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder
A study testing testing, evaluation, sampling in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, REM Sleep Behavior Disorder
- What is being tested?
- testing, evaluation, sampling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
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.
Read the 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.
- Conditions
- Parkinson Disease, REM Sleep Behavior Disorder
- Being tested
- testing, evaluation, sampling
- Keywords
- Lewy body disease, REM Sleep Behavior Disorder, Parkinson disease, Imaging, Bio-markers, Prospective cohort
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: testing, evaluation, sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of development of Lewy body diseases
idiopathic RBD group only
Measured: 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)
descriptive, intragroup analysis
Measured: 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
descriptive, intragroup analysis
Measured: 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
descriptive, intragroup analysis
Measured: 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)
descriptive, intragroup analysis
Measured: from baseline to 2-years and 4-years follow-up (iRBD group only)
Functional network changes predicted by the resting-state functional MRI
descriptive, intragroup analysis
Measured: from baseline to 2-years and 4-years follow-up (iRBD group only)
Degenerative brain changes predicted by [18F]FP-CIT PET
descriptive, intragroup analysis
Measured: from baseline to 2-years and 4-years follow-up (iRBD group only)
Functional network changes predicted by [18F]FDG PET
descriptive, intragroup analysis
Measured: from baseline to 2-years and 4-years follow-up (iRBD group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJun 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jee-Young Lee, Seoul National University Hospital
- Investigators
- Jee-Young Lee, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984137
- Sponsor's protocol ID
- 16-2013-101
- Status last verified
- Mar 2020
- First submitted
- 30 Nov 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Neuroimaging and Biomarker Cohort Study in Idiopathic Rapid Eye Movement(REM) Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT02984137
- Acronym / sponsor ID
- 16-2013-101
- Conditions
- Parkinson Disease, REM Sleep Behavior Disorder
- Keywords
- Lewy body disease, REM Sleep Behavior Disorder, Parkinson disease, Imaging, Bio-markers, Prospective cohort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Jun 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| idiopathic RBD group | Experimental | Other: testing, evaluation, samplingA 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. |
| incident PD group | Active comparator | Other: testing, evaluation, samplingA 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. |
| Control | Placebo comparator | Other: testing, evaluation, samplingControl group includes elderly controls without neurodegerative diseases examined by neurologists. Interventions as testing, evaluation, sampling at baseline only. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- A diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testing, evaluation, samplingneuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological \& neurocognitive status by using a predefined neuropsychological assessment battery. | Other | Control, idiopathic RBD group, incident PD group |
Primary outcome
Frequency of development of Lewy body diseases
Time frame: up to 4-years follow-up
idiopathic RBD group only
7 secondary outcomes
Parkinsonian motor symptoms score change measured by the unified Parkinson's disease rating scale (MDS-UPDRS)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Functional network changes predicted by the resting-state functional MRI
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Degenerative brain changes predicted by [18F]FP-CIT PET
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Functional network changes predicted by [18F]FDG PET
Time frame: from baseline to 2-years and 4-years follow-up (iRBD group only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee-Young Lee, MD, PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing testing, evaluation, sampling in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of development of Lewy body diseases (time frame: up to 4-years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.