Neuro-immune Interactome in Parkinson's Disease

This study will be observational and have a prospective case-control longitudinal design. Eligible subjects with idiopathic REM behavior disorder (RBD), Parkinson's disease with RBD, and healthy controls will be recruited. Subjects will undergo a sleep study to determine eligibility for the study and then in the study will undergo clinical assessments, including cognitive, sensory and motor clinical assessment, dopamine transporter scanning, and smell testing. Eligible subjects will undergo phlebotomy, lumbar puncture, stool and saliva collection, and genome-wide association scans at baseline and then undergo yearly sensory and motor clinical assessment to assess for phenoconversion to neurodegenerative disease. From blood and CSF samples, investigators will isolate mononuclear cells, and using cell immunologic and single cell genomic procedures, will look for the presence of T cells which autoreact with alpha-synuclein. Investigators will also look for the presence of increased clonality of T cells reflecting increased immune cell activation and the presence of cross reactivity of anti-alpha-synuclein T cells with microbial agents from subject gut stool samples.

NCT Number	NCT07026929
Lead Sponsor	Yale University Collaborators: Michael J. Fox Foundation for Parkinson's Research
Conditions	Parkinson Disease
Enrollment	94 participants
Start Date	2021-05-10
Primary Completion	2024-06-27 (estimated)
Study Completion	2031-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-21