The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder - PubMed
4 hours ago
- #neurodegenerative diseases
- #clinical trials
- #REM sleep behavior disorder
- The North American Prodromal Synucleinopathy (NAPS) study focuses on idiopathic/isolated rapid eye movement sleep behavior disorder (iRBD), a prodromal sign of neurodegenerative diseases like Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA).
- NAPS aims to overcome barriers in clinical trials for iRBD, such as limited access to well-characterized cohorts, inconsistent assessment protocols, and lack of validated biomarkers.
- The study involves nine academic centers across North America, enrolling over 500 individuals with iRBD and 60 matched controls, following a harmonized protocol with annual assessments.
- Assessments include standardized clinical evaluations of motor, cognitive, autonomic, psychiatric, sensory, and sleep functions, along with biospecimen collection and centralized analysis of polysomnography and neuroimaging data.
- The goal of NAPS is to facilitate clinical trials for neuroprotective therapies targeting synucleinopathy at early stages, aiming to delay or prevent progression to overt neurodegenerative diseases.