REM Sleep Behavior DisorderNAPSNCT03623672
North American Prodromal Synucleinopathy Consortium
An observational study of REM Sleep Behavior Disorder and Parkinson Disease, run by Washington University School of Medicine at 10 sites in 2 countries.
Trial summary
This study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease
- How many people
- 500 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 Aug 2018to 31 Jul 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic REM sleep behavior disorder, adults.
Who may be able to join
- Idiopathic REM sleep behavior disorder
Who cannot join
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
- Other neurological disorder
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02145
University of California Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Portland VA Medical Center
Portland, Oregon, 97239
Stanford University
Redwood City, California, 94063
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Banner Sun Health Research Institute
Sun City, Arizona, 85351
About this study
This study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
Read the detailed description
REM sleep behavior disorder (RBD) is a rare disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a ~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional lumbar puncture.
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease, Dementia With Lewy Bodies, Multiple System Atrophy, REM Sleep Parasomnias
- Keywords
- sleep, REM, rapid eye movement, parkinson, lewy body disease, dementia with lewy bodies, Multiple System Atrophy, parasomnia, synuclein, synucleinopathy
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease, Multiple System Atrophy, REM Sleep Parasomnias, Parasomnias, Synucleinopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Prodromal Synucleinopathy Rating Scale
Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start29 Aug 2018
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Minnesota, University of California, Los Angeles, McGill University, Emory University, Massachusetts General Hospital, National Institute on Aging (NIA), Stanford University, Portland VA Medical Center, Banner Health
- Responsible party
- Sponsor
- Investigators
- Yo-El Ju, MD, Principal investigator, Washington University School of MedicineBradley Boeve, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623672
- Sponsor's protocol ID
- 201712025
- Other IDs
- R34AG056639
- Acronym
- NAPS
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2018
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will develop a large database of potential neurocognitive and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, and cerebrospinal fluid from individuals with RBD. Since individuals with RBD frequently develop synucleinopathies including Parkinson Disease, Dementia with Lewy Bodies (DLB), and Multiple System Atrophy, we anticipate that the data and samples we collect will be valuable for investigators interested in synucleinopathies, other dementias such as Alzheimer's Disease (AD), and sleep disorders. The neurocognitive battery will contain all components of the Uniform Dataset version 3 (UDS 3) with the additional DLB module, to harmonize with research efforts in AD and DLB. Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD) to facilitate distribution to other investigators.
Publications
Postuma R, Vorasoot N, St Louis EK, Pelletier A, Lim MM, Elliott J, Gagnon JF, Gan-Or Z, Forsberg LK, Fields JA, Ross OA, Singer W, Huddleston DE, Bliwise DL, Avidan AY, Howell M, Schenck CH, McLeland J, Davis AA, Criswell SR, Videnovic A, During EH, Miglis MG, Boeve BF, Ju YS, McKeon A; as the North American Prodromal Synucleinopathy (NAPS) Consortium. IGLON5 Frequency in Idiopathic REM Sleep Behavior Disorder: A Multicenter Study. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200311. doi: 10.1212/NXI.0000000000200311. Epub 2024 Sep 13.
PubMed 39270144Elliott JE, Bryant-Ekstrand MD, Keil AT, Ligman BR, Lim MM, Zitser J, During EH, Gagnon JF, St Louis EK, Fields JA, Huddleston DE, Bliwise DL, Avidan AY, Schenck CH, McLeland J, Criswell SR, Davis AA, Videnovic A, Lee-Iannotti JK, Postuma R, Boeve BF, Ju YS, Miglis MG; for North American Prodromal Synucleinopathy (NAPS) Consortium. Frequency of Orthostatic Hypotension in Isolated REM Sleep Behavior Disorder. Neurology. 2023 Dec 12;101(24):e2545-e2559. doi: 10.1212/WNL.0000000000207883. Epub 2023 Oct 19.
PubMed 37857496
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North American Prodromal Synucleinopathy Consortium
- ClinicalTrials.gov ID
- NCT03623672
- Acronym / sponsor ID
- NAPS / 201712025
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease, Dementia With Lewy Bodies, Multiple System Atrophy, REM Sleep Parasomnias
- Keywords
- sleep, REM, rapid eye movement, parkinson, lewy body disease, dementia with lewy bodies, Multiple System Atrophy, parasomnia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Minnesota, University of California, Los Angeles, McGill University, Emory University, Massachusetts General Hospital, National Institute on Aging (NIA), Stanford University, Portland VA Medical Center, Banner Health
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 9 Aug 2018 (actual)
- 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 study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
Detailed description
REM sleep behavior disorder (RBD) is a rare disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a ~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional lumbar puncture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic REM sleep behavior disorder, adults.
Key inclusion criteria (1 listed)
- Idiopathic REM sleep behavior disorder
Key exclusion criteria (2 listed)
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
- Other neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prodromal Synucleinopathy Rating Scale
Time frame: 2 years
Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 39270144Postuma R, Vorasoot N, St Louis EK, Pelletier A, Lim MM, Elliott J, Gagnon JF, Gan-Or Z, Forsberg LK, Fields JA, Ross OA, Singer W, Huddleston DE, Bliwise DL, Avidan AY, Howell M, Schenck CH, McLeland J, Davis AA, Criswell SR, Videnovic A, During EH, Miglis MG, Boeve BF, Ju YS, McKeon A; as the North American Prodromal Synucleinopathy (NAPS) Consortium. IGLON5 Frequency in Idiopathic REM Sleep Behavior Disorder: A Multicenter Study. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200311. doi: 10.1212/NXI.0000000000200311. Epub 2024 Sep 13.
- Derived from this study: PubMed 37857496Elliott JE, Bryant-Ekstrand MD, Keil AT, Ligman BR, Lim MM, Zitser J, During EH, Gagnon JF, St Louis EK, Fields JA, Huddleston DE, Bliwise DL, Avidan AY, Schenck CH, McLeland J, Criswell SR, Davis AA, Videnovic A, Lee-Iannotti JK, Postuma R, Boeve BF, Ju YS, Miglis MG; for North American Prodromal Synucleinopathy (NAPS) Consortium. Frequency of Orthostatic Hypotension in Isolated REM Sleep Behavior Disorder. Neurology. 2023 Dec 12;101(24):e2545-e2559. doi: 10.1212/WNL.0000000000207883. Epub 2023 Oct 19.
- Individual participant dataSharing planned: Yes. This project will develop a large database of potential neurocognitive and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, and cerebrospinal fluid from individuals with RBD. Since individuals with RBD frequently develop synucleinopathies including Parkinson Disease, Dementia with Lewy Bodies (DLB), and Multiple System Atrophy, we anticipate that the data and samples we collect will be valuable for investigators interested in synucleinopathies, other dementias such as Alzheimer's Disease (AD), and sleep disorders. The neurocognitive battery will contain all components of the Uniform Dataset version 3 (UDS 3) with the additional DLB module, to harmonize with research efforts in AD and DLB. Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD) to facilitate distribution to other investigators.
Related trials for REM Sleep Behavior Disorder
RecruitingPhase 2
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
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Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
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Active, not recruitingObservational study
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
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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.
Yo-El Ju, MD principal investigator
Washington University School of Medicine
Bradley Boeve, MD principal investigator
Mayo Clinic
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder and Parkinson Disease, run by Washington University School of Medicine at 10 sites in 2 countries.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prodromal Synucleinopathy Rating Scale (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623672, which also lists 2 linked publications.
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 6 Nov 2024.