North American Prodromal Synucleinopathy Consortium

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03623672

Acronym

NAPS

Enrollment

500

Registered

2018-08-09

Start date

2018-08-29

Completion date

2026-07-31

Last updated

2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sleep, REM, rapid eye movement, parkinson, lewy body disease, dementia with lewy bodies, Multiple System Atrophy, parasomnia, synuclein, synucleinopathy

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Prodromal Synucleinopathy Rating Scale	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.

Countries

Canada, United States

Outcome results