PROJECT SUMMARY/ABSTRACT
This proposal outlines plans to collect and share biospecimens with the Biospecimen Exchange for
Neurological Disorders (BioSEND) repository, the National Institute of Neurological Disorders and Stroke
(NINDS) biomarker repository. This administrative supplement would build on the aims of a recently awarded
R01 which will evaluate potential microbiome-gut-brain mechanisms in prodromal and symptomatic Lewy body
diseases. The R01 will be recruiting a unique study cohort, which includes participants with idiopathic rapid eye
movement (REM) Sleep behavior disorder (iRBD). REM Sleep Behavior Disorder is one of the earliest and most
specific indicators of Lewy body diseases, providing a prodromal cohort to evaluate early disease mechanisms.
Additionally, we will be enrolling two symptomatic cohorts, a Parkinson’s disease cohort (PD) and Dementia with
Lewy body disease (DLB) cohort. These cohorts provide an opportunity to conduct a novel evaluation of the
presence of a bloom in sulfate reducing bacteria/dysbiosis and intestinal permeability. We will determine if these
are present early in the disease and are associated with known disease processes (increases in α-synuclein,
midbrain degeneration and clinical outcomes). The R01 project will evaluate these key mechanisms through the
collection of urine, blood, and stool biospecimen samples in addition to advanced MRI and a breath test. This
administrative supplement would support sharing of these biospecimens with BioSEND, which banks
biospecimens for more than 50 different studies. The repository is developed to support high quality data
collection and banking, providing specimens available to researchers around the world. The administrative
supplement will support the implementation of study specific manual of procedures already developed by
BioSEND to facilitate sharing of biospecimens. BioSEND’s goal is to make it easy for researchers to identify the
samples they need for their research through online biospecimen catalogs that can be queried by approved
researchers. The administrative supplement would support sharing of this unique cohort with investigators
around the world. This will increase the R01 project’s likelihood to exert a sustained, powerful influence on the
study of Lewy body diseases.