REM Sleep Behavior DisorderNAPS2NCT05826457
North American Prodromal Synucleinopathy Consortium Stage 2
An observational study of REM Sleep Behavior Disorder and Parkinson Disease, run by Washington University School of Medicine at 9 sites in 2 countries.
Trial summary
This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls 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 olderHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia
- How many people
- 500 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Aug 2022to 1 May 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Idiopathic REM sleep behavior disorder, adults.
Who may be able to join
- Polysomnogram-confirmed RBD by ICSD-3 criteria
- Capable of providing informed consent at time of study enrollment
- Age > 18 years
- Ability to provide written consent
- Age > 18 years
- Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
- Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
- Normal capacity to perform complex activities of daily living independently based on informant or physician report
Who cannot join
- Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
- Narcolepsy-associated RBD
- RBD secondary to any known cause except prodromal synucleinopathy.
- Participation in a clinical trial, except by specific permission by the Executive Committee
- In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
- History of dream enactment behavior to suggest RBD
Show all 12Show fewer
- Parkinsonism, MSA, dementia, or mild cognitive impairment
- Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
- Contraindications to complete MRI.
- Contraindications to lumbar puncture.
- Participation in a clinical trial, except by specific permission by the Executive Committee
- In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 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, 55414
Oregon Health Sciences University
Portland, Oregon, 97239
Stanford University
Redwood City, California, 94063
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Canada1 site
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1
About this study
This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls 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 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 Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.
RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.
Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies, Multiple System Atrophy, REM Sleep Parasomnias
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease, Multiple System Atrophy, REM Sleep Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RBD group | Clinical observation involving annual visits to a study site for up to 5 years. | |
| control group | Clinical observation involving annual visits to a study site for up to 5 years. |
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: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start12 Aug 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
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 of Neurological Disorders and Stroke (NINDS), Stanford University, National Institutes of Health (NIH), Oregon Health and Science University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Yo-El Ju, MD, MCSI, Principal investigator, Washington University School of MedicineBrad Boeve, MD, Principal investigator, Mayo ClinicRon Postuma, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826457
- Sponsor's protocol ID
- 202110108
- Other IDs
- U19AG071754
- Acronym
- NAPS2
- Status last verified
- May 2026
- First submitted
- 8 Feb 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified subject level data will be shared upon approved data request. This project will develop a large database of potential neurocognitive, neuroimaging, genetic, and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, RNA, and cerebrospinal fluid. A large part of the clinical battery is the Uniform Dataset version 3, will be uploaded to the National Alzheimer's Coordinating Center (NACC). Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD). Genetic data will be submitted to the National Institute on Aging Genetics of Alzheimer's Disease Data Storage (NIAGADS). Brain MRI and DaTscan imaging data will be uploaded to the Laboratory of NeuroImaging (LONI). Polysomnogram data will be uploaded to the National Sleep Research Resource (NSRR).
Publications
Boeve BF, Nie Y, Lu R, De La Cruz H, Avidan AY, Bliwise DL, Campbell MC, Criswell SR, Davis AA, Duff K, Elliott J, Ferman TJ, Fields JA, Forsberg LK, Gagnon JF, Howell M, Huddleston DE, Lim MM, Locke J, McCarter SJ, McLeland J, Miglis MG, Miyagawa T, Neilson LE, Nichols K, Pelletier A, Schenck CH, Louis EKS, Sum-Ping O, Trotti LM, Videnovic A, Xiong C, Postuma R, Ju YS; NAPS Consortium. The Prodromal Synucleinopathy Rating Scale: An Assessment in Patients With REM Sleep Behavior Disorder. Neurology. 2026 Jul 14;107(1):e218176. doi: 10.1212/WNL.0000000000218176. Epub 2026 Jun 16.
PubMed 42302227Lim MM, Neilson LE, Elliott JE, Hoang-Dang B, Locke JR, Cunningham H, Brewer J, Dennis L, Dovek L, Pelletier A, St Louis EK, McCarter SJ, Miyagawa T, Davis AA, McLeland JS, Criswell S, Howell MJ, Schenck CH, Avidan AY, Trotti LM, Bliwise DL, Huddleston DE, Videnovic A, Miglis MG, Sum-Ping O, Lee-Iannotti JK, Shprecher DR, Duff K, Ferman TJ, Campbell MC, Fields JA, Gagnon JF, Kotzbauer P, Singer W, Gan-Or Z, Ross OA, Kantarci K, Lowe VJ, Hu XP, Ehgoetz Martens KA, Hu MT, Xiong C, Postuma RB, Boeve BF, Ju YS; NAPS Consortium for RBD. The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder. Sleep Adv. 2026 Jan 19;7(1):zpag007. doi: 10.1093/sleepadvances/zpag007. eCollection 2026.
PubMed 41725984
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North American Prodromal Synucleinopathy Consortium Stage 2
- ClinicalTrials.gov ID
- NCT05826457
- Acronym / sponsor ID
- NAPS2 / 202110108
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies, Multiple System Atrophy, REM Sleep Parasomnias
- 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 of Neurological Disorders and Stroke (NINDS), Stanford University, National Institutes of Health (NIH), Oregon Health and Science University, National Institute on Aging (NIA)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 24 Apr 2023 (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 REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
Detailed description
REM sleep behavior disorder (RBD) is a 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 Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.
RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.
Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBD group | – | –Clinical observation involving annual visits to a study site for up to 5 years. |
| control group | – | –Clinical observation involving annual visits to a study site for up to 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic REM sleep behavior disorder, adults.
Key inclusion criteria (8 listed)
- Polysomnogram-confirmed RBD by ICSD-3 criteria
- Capable of providing informed consent at time of study enrollment
- Age > 18 years
- Ability to provide written consent
- Age > 18 years
Key exclusion criteria (12 listed)
- Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
- Narcolepsy-associated RBD
- RBD secondary to any known cause except prodromal synucleinopathy.
- Participation in a clinical trial, except by specific permission by the Executive Committee
- In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
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: up to 5 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 13 May 2026.
- Derived from this study: PubMed 42302227Boeve BF, Nie Y, Lu R, De La Cruz H, Avidan AY, Bliwise DL, Campbell MC, Criswell SR, Davis AA, Duff K, Elliott J, Ferman TJ, Fields JA, Forsberg LK, Gagnon JF, Howell M, Huddleston DE, Lim MM, Locke J, McCarter SJ, McLeland J, Miglis MG, Miyagawa T, Neilson LE, Nichols K, Pelletier A, Schenck CH, Louis EKS, Sum-Ping O, Trotti LM, Videnovic A, Xiong C, Postuma R, Ju YS; NAPS Consortium. The Prodromal Synucleinopathy Rating Scale: An Assessment in Patients With REM Sleep Behavior Disorder. Neurology. 2026 Jul 14;107(1):e218176. doi: 10.1212/WNL.0000000000218176. Epub 2026 Jun 16.
- Derived from this study: PubMed 41725984Lim MM, Neilson LE, Elliott JE, Hoang-Dang B, Locke JR, Cunningham H, Brewer J, Dennis L, Dovek L, Pelletier A, St Louis EK, McCarter SJ, Miyagawa T, Davis AA, McLeland JS, Criswell S, Howell MJ, Schenck CH, Avidan AY, Trotti LM, Bliwise DL, Huddleston DE, Videnovic A, Miglis MG, Sum-Ping O, Lee-Iannotti JK, Shprecher DR, Duff K, Ferman TJ, Campbell MC, Fields JA, Gagnon JF, Kotzbauer P, Singer W, Gan-Or Z, Ross OA, Kantarci K, Lowe VJ, Hu XP, Ehgoetz Martens KA, Hu MT, Xiong C, Postuma RB, Boeve BF, Ju YS; NAPS Consortium for RBD. The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder. Sleep Adv. 2026 Jan 19;7(1):zpag007. doi: 10.1093/sleepadvances/zpag007. eCollection 2026.
- Individual participant dataSharing planned: Yes. De-identified subject level data will be shared upon approved data request. This project will develop a large database of potential neurocognitive, neuroimaging, genetic, and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, RNA, and cerebrospinal fluid. A large part of the clinical battery is the Uniform Dataset version 3, will be uploaded to the National Alzheimer's Coordinating Center (NACC). Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD). Genetic data will be submitted to the National Institute on Aging Genetics of Alzheimer's Disease Data Storage (NIAGADS). Brain MRI and DaTscan imaging data will be uploaded to the Laboratory of NeuroImaging (LONI). Polysomnogram data will be uploaded to the National Sleep Research Resource (NSRR).
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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, MCSI principal investigator
Washington University School of Medicine
Brad Boeve, MD principal investigator
Mayo Clinic
Ron Postuma, MD principal investigator
McGill University
9 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 9 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 8 inclusion and 12 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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: up to 5 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 NCT05826457, 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 13 May 2026.