North American Prodromal Synucleinopathy Consortium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Disease, Dementia With Lewy Bodies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Prodromal Synucleinopathy Rating Scale [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Idiopathic REM sleep behavior disorder
Exclusion criteria
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
- Other neurological disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Banner Sun Health Research Institute — Sun City
- University of California Los Angeles — Los Angeles
- Stanford University — Redwood City
- Emory University — Atlanta
- Massachusetts General Hospital — Boston
- University of Minnesota — Minneapolis
- Mayo Clinic — Rochester
- Washington University — St Louis
- … and 1 more center
Canada · 1 center
- McGill University — Montreal
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 Beh PMID 39270144
- Elliott 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 Behavio PMID 37857496
Identifiers
NCT: NCT03623672 · 201712025 · R34AG056639