NAPS2 Administrative Core

ABSTRACT: NAPS2 ADMINISTRATIVE CORE Synucleinopathies including Parkinson disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA) in aggregate afflict ~2 million Americans, and lead to progressive neurodegeneration and loss of function toward severe disability and death.

Rapid eye movement (REM) Sleep Behavior Disorder (RBD) usually reflects a prodromal synucleinopathy, and presents a window of opportunity when treatment may be effective to prevent or slow the progression to overt synucleinopathy.

The North American Prodromal Synucleinopathy (NAPS) Consortium for RBD was established in 2018 to prepare for such neuroprotective treatment trials.

As NAPS1?the current, R34-supported stage of NAPS?we have been very successful in engaging key RBD researchers and cohorts across North America.

NAPS1 has been extremely productive: >200 participants have thus far been enrolled across 10 Sites, and have completed standardized, comprehensive assessments.

We established key administrative procedures and processes in parallel with rapid enrollment, and NAPS1 functions smoothly as a transparent, efficient Consortium.

To address important questions about biomarkers and phenotypic trajectories in prodromal synucleinopathy, we propose Stage 2 of NAPS, or NAPS2, to enable longitudinal followup and expanded biomarker collection. NAPS2 will build and substantially expand upon NAPS1, to establish 8 Cores that support a central research Project.

The Administrative Core will formalize and streamline the administrative tasks across NAPS2 and all its components.

The current Sites will come under the umbrella of the Administrative Core as they continue into NAPS2, and the Administrative Core will oversee the activities and interactions between all NAPS2 components.

The Aims of the Administrative Core are to 1) coordinate all NAPS2 Cores, Sites, Project, personnel, and resources; 2) facilitate communication within and outside of NAPS; 3) safeguard data quality and consistency across the NAPS Consortium; 4) promote research in RBD; and 5) guarantee compliance with required regulatory bodies.

The NAPS2 Administrative Core will oversee the inter-relationships between NAPS2 components with the goal of an efficient and productive Consortium.

Through the proposed aims, the Administrative Core will enable all NAPS2 components to perform optimally, toward the goal of neuroprotective clinical trials to slow or stop the progression of synucleinopathies.