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North American Prodromal Synucleinopathy Consortium (NAPS)

The Washington University logo

The Washington University

Status

Invitation-only

Conditions

Multiple System Atrophy
REM Sleep Behavior Disorder
REM Sleep Parasomnias
Parkinson Disease
Dementia With Lewy Bodies
Lewy Body Disease

Study type

Observational

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT03623672
R34AG056639 (U.S. NIH Grant/Contract)
201712025

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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