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| ID | Type | Description | Link |
|---|---|---|---|
| R34AG056639 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of Minnesota | OTHER |
| University of California, Los Angeles | OTHER |
| McGill University |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Idiopathic REM sleep behavior disorder, adults.
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| Name | Affiliation | Role |
|---|---|---|
| Yo-El Ju, MD | Washington University School of Medicine | Principal Investigator |
| Bradley Boeve, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39270144 | Derived | 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. | |
| 37857496 |
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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.
Data will be made available after primary analyses planned by NAPS investigators in 2020. Data will be available indefinitely.
IPD and sample requests will be determined by a Steering Committee
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| OTHER |
| Emory University | OTHER |
| Massachusetts General Hospital | OTHER |
| National Institute on Aging (NIA) | NIH |
| Stanford University | OTHER |
| Portland VA Medical Center | FED |
| Banner Health | OTHER |
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Blood (plasma, buffy coat, extracted DNA) and cerebrospinal fluid
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University | Redwood City | California | 94063 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02145 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| McGill University | Montreal | Quebec | HGH 2R9 | Canada |
| Derived |
| 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 Behavior Disorder. Neurology. 2023 Dec 12;101(24):e2545-e2559. doi: 10.1212/WNL.0000000000207883. Epub 2023 Oct 19. |
| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D010300 | Parkinson Disease |
| D020961 | Lewy Body Disease |
| D019578 | Multiple System Atrophy |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D000080874 | Synucleinopathies |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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